URGENT FIELD SAFETY NOTICE

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URGENT FIELD SAFETY NOTICE This Field Safety Notice calls attention to a safety aspect of the Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve or the LH130 Single, Sterile Over-pressure Safety Valve Attention: Chief of Perfusion; Director of Operating Room Services; Director of Biomedical Services; Risk Management Affected Product: LH130 Single, Sterile Over-pressure Safety Valve (often referred to as Vent Valve), LN130B Non-Sterile Over-pressure Safety Valve, Extracorporeal Tubing Set containing the Over-pressure Safety Valve Action: Advisory WHAT TO DO NEXT REASON FOR CORRECTION This Field Safety Notice calls attention to a situation that may arise with the LN130B over-pressure safety valve (OPS valve) within your Terumo Extracorporeal Tubing Set or the LH130 single, sterile OPS valve, and recommends how to check to ensure the duckbill valve within the OPS valve is patent and allows flow through the valve. The LN130B or LH130 OPS valves are to prevent reversal of blood flow and the prevention of air embolism as well as limit excessive negative and positive pressure in the vent catheter. The OPS valve allows for flow in only one direction (from the catheter in the heart to the cardiotomy reservoir). Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the OPS valve. Terumo CVS has received no reports of patient injury due to this issue. Review this Urgent Field Safety Notice and follow the instructions in the Recommended Action section of this letter. Note that Terumo CVS is not requesting removal or return of product as a result of this Field Safety Notice activity. If you have questions, contact your local Terumo representative. POTENTIAL HAZARD No flow through the duckbill valve within the OPS valve would prevent the ability to vent blood from the left ventricle, potentially resulting in distension of the ventricle. If the distension is prolonged, this may result in severe ventricular dysfunction. RECOMMENDED ACTIONS Note: This is an advisory Field Safety Notice. Terumo CVS is not requesting removal or return of product as a result of this activity. Terumo Cardiovascular Systems/ Terumo Europe N.V. Page 1 of 13

Affected Product: LN130B and LH130 OPS Valves Terumo CVS recommends that the customer test the valve in the tubing pack prior to use to ensure flow through the valve. 1. A member of the surgical team shall place the sterile end of the tubing with LN130B or LH130 OPS valve in a basin of fluid on the sterile field and initiate pump flow to ensure flow through the valve. 2. If no fluid flow is evident through the duckbill valve after the test described above, maintain the tubing in the basin and place gloved fingers over the positive and negative umbrella relief valves (see diagram below). Turn on the roller pump at approximately 500 ml/minute and allow up to 30 seconds to create negative pressure on the duckbill valve to initiate fluid flow through the device. Once the duckbill is opened, it will operate as intended. Turn off roller pump. 3. If flow is still not observed, then we recommend removing the valve and replacing it with a single, sterile OPS valve. Please return the defective LN130B or LH130 OPS valve to Terumo. 4. If you do not have a single, sterile OPS valve available, open a new Extracorporeal Tubing Set and use the line and OPS valve from it. AFFECTED POPULATION Any patient who is exposed to a Extracorporeal Tubing Set with LN130B OPS valve or a LH130 single, sterile OPS valve. AFFECTED PRODUCT Catalog Number Product Description Lot Number Range LH130 LN130B Single, Sterile OPS (Vent) Valve Non sterile OPS (Vent) Valve Lot # RK11, RK20, RL02, RL08, RM20, RP08, TE27, TF08, TF14, TF21, TH06, TH16, TL21, TP14, UA11, UC08, UD14, UD28, UE05, UE18, UF09, UG06, UL12, UM10, VA02, VC06 Lot # RL15, RL22, RM27, RP01, RP22, TA12, TE17, TE20, TE22, TE23, TE24, TE25, TF01, TF04, TF06, TF07, TF08, TF15, TF18, TF19, TF20, TF21, TF30, TG01, TG04, TG05, TG08, TG12, TG15, TG16, TG17, TG19, TG22, TG23, TG24, TG25, TH06, TH07, TH08, TH09, TH10, TH13, TH15, TH17, TH31, TK03, TK04, TK06, TK07, TK10, TK12, TK14, TK17, TK18, TK24, TL23, TL25, TL28, TM01, TM05, TM07, TM09, TM23, TM26, TM28, TN02, TN05, TN19, TN23, TP01, UA04, Terumo Cardiovascular Systems/Terumo Europe N.V. Page 2 of 13

Affected Product: LN130B and LH130 OPS Valves CX AU038X Extracorporeal Tubing Set 1602458 CX AU100X Extracorporeal Tubing Set 1705327 CX AU101X Extracorporeal Tubing Set 1608281 till 1608283 CX AU102X Extracorporeal Tubing Set 1608111 CX BE062X Extracorporeal Tubing Set 1508150 till 1610286 CX BE063X Extracorporeal Tubing Set 1509358 till 1701295 CX BE066X Extracorporeal Tubing Set 1508106 till 1610150 CX BE068X Extracorporeal Tubing Set 1510018 till 1608444 CX BE069X Extracorporeal Tubing Set 1509276 till 1704106 CX BE093X Extracorporeal Tubing Set 1611202 till 1705265 CX BE094X Extracorporeal Tubing Set 1701042 CX BL040X Extracorporeal Tubing Set 1606021 till 1606024 CX BL047X Extracorporeal Tubing Set 1606124 till 1608137 CX BL053X Extracorporeal Tubing Set 1611260 till 1701165 CX CH034X Extracorporeal Tubing Set 1510126 till 1512222 CX CH049X Extracorporeal Tubing Set 1510305 till 1609149 CX CH062X Extracorporeal Tubing Set 1602483 till 1611248 CX CH071X Extracorporeal Tubing Set 1603149 CX CH088X Extracorporeal Tubing Set 1703348 CX CH094X Extracorporeal Tubing Set 1610337 till 1611032 CX CH096X Extracorporeal Tubing Set 1610361 UC01, UC29, UD07, UD21, UD28, UE04, UF23, UF31, UG20, UH18, UK29, UL12, UL19, UL26, UM17, UM24, UN28, UP12, VC13, VD20, VE03, VE24, VF15 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 3 of 13

Affected Product: LN130B and LH130 OPS Valves CX CH102X Extracorporeal Tubing Set 1701331 till 1705165 CX CH105X Extracorporeal Tubing Set 1702330 till 1705169 CX CR014 Extracorporeal Tubing Set 1609170 CX CY005 Extracorporeal Tubing Set 1703307 till 1704041 CX CY006 Extracorporeal Tubing Set 1703312 till 1704046 CX DB05 Extracorporeal Tubing Set 1601168 CX DB080 Extracorporeal Tubing Set 1509069 till 1706029 CX DB317X Extracorporeal Tubing Set 1702327 till 1702328 CX DB318 Extracorporeal Tubing Set 1701086 CX DB319 Extracorporeal Tubing Set 1701088 CX DB320 Extracorporeal Tubing Set 1701160 CX DB321 Extracorporeal Tubing Set 1510176 till 1701205 CX DB329 Extracorporeal Tubing Set 1512152 till 1512153 CX DB334X Extracorporeal Tubing Set 1702074 CX DB351X Extracorporeal Tubing Set 1606012 till 1609221 CX DB379X Extracorporeal Tubing Set 1602431 till 1701337 CX DB401X Extracorporeal Tubing Set 1701278 CX DB407X Extracorporeal Tubing Set 1705422 CX DB408X Extracorporeal Tubing Set 1705420 CX DB409X Extracorporeal Tubing Set 1705423 CX DB421X Extracorporeal Tubing Set 1606113 till 1607201 CX DB331X Extracorporeal Tubing Set 1705419 till 1706076 CX DB336 Extracorporeal Tubing Set 1510309 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 4 of 13

Affected Product: LN130B and LH130 OPS Valves CX DB337 Extracorporeal Tubing Set 1510310 CX DB338 Extracorporeal Tubing Set 1510308 CX DB387X Extracorporeal Tubing Set 1601152 CX DB388X Extracorporeal Tubing Set 1601153 CX DB404X Extracorporeal Tubing Set 1603293 CX DB421X Extracorporeal Tubing Set 1601420 till 1602345 CX DB459X Extracorporeal Tubing Set 1705421 CX DB462 Extracorporeal Tubing Set 1511160 CX DB463 Extracorporeal Tubing Set 1511134 CX DB464 Extracorporeal Tubing Set 1602379 till 1701200 CX DB466 Extracorporeal Tubing Set 1606002 till 1609285 CX DB474X Extracorporeal Tubing Set 1601427 CX DB475X Extracorporeal Tubing Set 1601428 CX DB478 Extracorporeal Tubing Set 1601314 CX DB481X Extracorporeal Tubing Set 1605397 CX DB483X Extracorporeal Tubing Set 1605396 CX DB484X Extracorporeal Tubing Set 1605395 CX DB497X Extracorporeal Tubing Set 1603365 till 1705348 CX DB524 Extracorporeal Tubing Set 1608168 till 1701211 CX DK043 Extracorporeal Tubing Set 1601107 till 1604027 CX DK068 Extracorporeal Tubing Set 1508196 till 1704188 CX DK086 Extracorporeal Tubing Set 1511355 CX DK087 Extracorporeal Tubing Set 1511071 till 1604034 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 5 of 13

Affected Product: LN130B and LH130 OPS Valves CX DK098 Extracorporeal Tubing Set 1512220 till 1612155 CX DK099 Extracorporeal Tubing Set 1511487 till 1701364 CX DK102 Extracorporeal Tubing Set 1608242 till 1706056 CX DK103 Extracorporeal Tubing Set 1611412 CX DK107 Extracorporeal Tubing Set 1703066 CX FAC01 Extracorporeal Tubing Set 1509335 till 1704166 CX FAC68 Extracorporeal Tubing Set 1607163 till 1702249 CX FR100 Extracorporeal Tubing Set 1508230 till 1602667 CX FR169 Extracorporeal Tubing Set 1508297 till 1512178 CX FR204X Extracorporeal Tubing Set 1604266 till 1605351 CX FR221 Extracorporeal Tubing Set 1701207 till 1703013 CX FR222 Extracorporeal Tubing Set 1606373 till 1704191 CX GE092X Extracorporeal Tubing Set 1508121 till 1706139 CX GE101 Extracorporeal Tubing Set 1508186 till 1702314 CX GE115X Extracorporeal Tubing Set 1604265 CX GE134X Extracorporeal Tubing Set 1508169 till 1705034 CX GE136 Extracorporeal Tubing Set 1509208 till 1702335 CX GE135 Extracorporeal Tubing Set 1508040 till 1703322 CX GE155 Extracorporeal Tubing Set 1608405 CX GE157 Extracorporeal Tubing Set 1508156 till 1603133 CX GE157X Extracorporeal Tubing Set 1604259 till 1702165 CX GE166X Extracorporeal Tubing Set 1508295 till 1704056 CX GE173X Extracorporeal Tubing Set 1508077 till 1705329 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 6 of 13

Affected Product: LN130B and LH130 OPS Valves CX GE180 Extracorporeal Tubing Set 1509310 till 1706018 CX GE181X Extracorporeal Tubing Set 1601312 till 1705414 CX GE193 Extracorporeal Tubing Set 1510130 till 1702017 CX GE195X Extracorporeal Tubing Set 1509221 till 1704039 CX GE204X Extracorporeal Tubing Set 1511060 till 1702010 CX GE211X Extracorporeal Tubing Set 1602490 till 1604062 CX GE216X Extracorporeal Tubing Set 1607434 CX GE218 Extracorporeal Tubing Set 1607383 till 1609381 CX GG005 Extracorporeal Tubing Set 1509148 till 1512015 CX GG006 Extracorporeal Tubing Set 1509306 till 1608008 CX GG009 Extracorporeal Tubing Set 1509346 till 1705159 CX GG012 Extracorporeal Tubing Set 1512016 till 1608235 CX GG016 Extracorporeal Tubing Set 1511441 till 1703131 CX GG038 Extracorporeal Tubing Set 1609057 till 1610015 CX GG039 Extracorporeal Tubing Set 1608244 till 1703189 CX GG041 Extracorporeal Tubing Set 1703190 CX GG042 Extracorporeal Tubing Set 1611349 CX GG045 Extracorporeal Tubing Set 1703354 CX GG046 Extracorporeal Tubing Set 1703353 CX IC002 Extracorporeal Tubing Set 1603257 CX IS019 Extracorporeal Tubing Set 1512012 till 1701174 CX IS021 Extracorporeal Tubing Set 1512237 till 1701173 CX IS022 Extracorporeal Tubing Set 1512014 till 1701176 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 7 of 13

Affected Product: LN130B and LH130 OPS Valves CX IS039 Extracorporeal Tubing Set 1511097 till 1511100 CX IS041 Extracorporeal Tubing Set 1601096 till 1701171 CX IS055 Extracorporeal Tubing Set 1509228 till 1702053 CX IS057 Extracorporeal Tubing Set 1603163 till 1609313 CX IS061 Extracorporeal Tubing Set 1702107 CX IS062 Extracorporeal Tubing Set 1509019 till 1609087 CX IS071 Extracorporeal Tubing Set 1602333 till 1701339 CX IS082 Extracorporeal Tubing Set 1601310 till 1601388 CX IS083 Extracorporeal Tubing Set 1702196 CX IS088X Extracorporeal Tubing Set 1705005 CX IS089X Extracorporeal Tubing Set 1705006 CX IT090X Extracorporeal Tubing Set 1703262 till 1705334 CX IT095X Extracorporeal Tubing Set 1509168 till 1704075 CX IT096X Extracorporeal Tubing Set 1509170 till 1705332 CX IT139X Extracorporeal Tubing Set 1511211 till 1605168 CX IT160X Extracorporeal Tubing Set 1608174 till 1705244 CX IT223X Extracorporeal Tubing Set 1508331 till 1705206 CX IT226X Extracorporeal Tubing Set 1508266 till 1705288 CX IT228X Extracorporeal Tubing Set 1511263 till 1703319 CX IT246X Extracorporeal Tubing Set 1509200 till 1704007 CX IT254X Extracorporeal Tubing Set 1510282 till 1705293 CX IT259X Extracorporeal Tubing Set 1602273 till 1705015 CX IT290X Extracorporeal Tubing Set 1606141 till 1705296 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 8 of 13

Affected Product: LN130B and LH130 OPS Valves CX IT291X Extracorporeal Tubing Set 1703285 till 1705339 CX IT292X Extracorporeal Tubing Set 1703288 till 1705340 CX IT304X Extracorporeal Tubing Set 1705301 CX IT304X Extracorporeal Tubing Set 1611345 till 1705301 CX IT305X Extracorporeal Tubing Set 1704136 till 1704137 CX IT306 Extracorporeal Tubing Set 1702299 till 1705303 CX IT314X Extracorporeal Tubing Set 1704132 CX NG002 Extracorporeal Tubing Set 1608016 CX PL083 Extracorporeal Tubing Set 1510298 till 1510326 CX QE12 Extracorporeal Tubing Set 1509183 till 1705051 CX QE4 Extracorporeal Tubing Set 1510037 till 1702179 CX ROCA Extracorporeal Tubing Set 1508281 till 1702151 CX RU046 Extracorporeal Tubing Set 1511169 till 1705155 CX RU075 Extracorporeal Tubing Set 1612216 CX RU100 Extracorporeal Tubing Set 1509214 till 1705025 CX RU100X Extracorporeal Tubing Set 1510260 till 1604246 CX RU101X Extracorporeal Tubing Set 1508060 till 1705093 CX RU103 Extracorporeal Tubing Set 1510157 till 1705210 CX RU103X Extracorporeal Tubing Set 1509223 till 1702202 CX RU124 Extracorporeal Tubing Set 1603427 till 1609168 CX RU125X Extracorporeal Tubing Set 1603403 till 1705091 CX SA021X Extracorporeal Tubing Set 1608332 CX SA022X Extracorporeal Tubing Set 1608331 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 9 of 13

Affected Product: LN130B and LH130 OPS Valves CX SA024X Extracorporeal Tubing Set 1610041 CX SA030X Extracorporeal Tubing Set 1612066 CX SA039X Extracorporeal Tubing Set 1701222 CX SE013 Extracorporeal Tubing Set 1605061 till 1609320 CX SE030 Extracorporeal Tubing Set 1604247 CX SE037 Extracorporeal Tubing Set 1604248 CX SL009X Extracorporeal Tubing Set 1509139 till 1705388 CX SL017X Extracorporeal Tubing Set 1604010 till 1702007 CX SP022 Extracorporeal Tubing Set 1508172 till 1704103 CX SP034XC Extracorporeal Tubing Set 1510317 till 1702320 CX SP049X Extracorporeal Tubing Set 1509339 till 1704027 CX SP054A Extracorporeal Tubing Set 1508191 till 1703103 CX SP054B Extracorporeal Tubing Set 1508174 till 1703103 CX SP064 Extracorporeal Tubing Set 1511077 till 1603308 CX SP066XA Extracorporeal Tubing Set 1509260 till 1510314 CX SP066XB Extracorporeal Tubing Set 1508036 till 1703211 CX SP066XC Extracorporeal Tubing Set 1609116 till 1704028 CX SP070 Extracorporeal Tubing Set 1508173 till 1704091 CX SP076A Extracorporeal Tubing Set 1512235 till 1602425 CX SP076B Extracorporeal Tubing Set 1603098 till 1703209 CX SP079 Extracorporeal Tubing Set 1509038 till 1702160 CX SP091 Extracorporeal Tubing Set 1510073 till 1608045 CX SV055 Extracorporeal Tubing Set 1508086 till 1705007 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 10 of 13

Affected Product: LN130B and LH130 OPS Valves CX SV056 Extracorporeal Tubing Set 1509345 till 1603090 CX SV059 Extracorporeal Tubing Set 1603006 till 1703321 CX SV065 Extracorporeal Tubing Set 1605189 till 1607372 CX SV072 Extracorporeal Tubing Set 1705124 CX SV073 Extracorporeal Tubing Set 1706016 till 1706089 CX TES014 Extracorporeal Tubing Set 1510047 till 1609305 CX UK224 Extracorporeal Tubing Set 1509377 till 1703242 CX UK325 Extracorporeal Tubing Set 1508065 till 1509238 CX UK343 Extracorporeal Tubing Set 1508113 till 1706274 CX UK352 Extracorporeal Tubing Set 1702048 till 1704102 CX UK371 Extracorporeal Tubing Set 1508070 till 1703114 CX UK437 Extracorporeal Tubing Set 1510161 till 1701045 CX UK440 Extracorporeal Tubing Set 1605183 CX UK448 Extracorporeal Tubing Set 1601401 till 1703206 CX UK460 Extracorporeal Tubing Set 1603084 CX UK467 Extracorporeal Tubing Set 1604263 CX UK484 Extracorporeal Tubing Set 1612197 till 1704158 CX UK486 Extracorporeal Tubing Set 1611187 CX UK487 Extracorporeal Tubing Set 1701183 CX UK488 Extracorporeal Tubing Set 1706078 CUSTOMER INSTRUCTIONS Review this Field Safety Notice and the Recommended Actions. Assure that all users receive notice of this issue. Confirm receipt of this Field Safety Notice by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. Terumo Cardiovascular Systems/Terumo Europe N.V. Page 11 of 13

Affected Product: LN130B and LH130 OPS Valves Test the OPS valve for flow prior to going on cardiopulmonary bypass by using the instructions provided in this letter. To return defective OPS valves, follow your complaint reporting protocol and contact Terumo. QUESTIONS? We encourage you to contact your local Terumo sales organization with any questions or concerns. REPORTING Any adverse event experienced with the use of this product, and/or quality problems shall immediately be reported to your local Terumo sales organization. We confirm that this Field Safety Notice has also been notified to your national Competent Authority. Organisation (to be completed by the sales or dealer) Contact name (function) Contact phone, mobile, email Terumo Cardiovascular Systems/Terumo Europe N.V. Page 12 of 13

Affected Product: LN130B and LH130 OPS Valves FIELD SAFETY NOTICE - CUSTOMER REPLY FORM Affected Product: LH130 Single, Sterile Over-pressure Safety Valve (often referred to as Vent Valve), LN130B Non-Sterile Over-pressure Safety Valve, Extracorporeal Tubing Set containing the Over-pressure Safety Valve Action: Advisory Please complete, sign and e-mail or fax this back: To: E-mail/Telefax: Client number Hospital Name City Country Our records indicate that you have received devices from the affected population. Catalog Number Product Description Lot number By completion and return of this form, I am confirming receipt, reading and acting on this Field Safety Notice. Person Responding [Please Print] Title Phone Number Signature Date FSN1702A [EN] Terumo Cardiovascular Systems/Terumo Europe N.V. Page 13 of 13

FSCA 1702 - ANNEX I Involved lot numbers for OPS Valve single use, sterile (LH130) and OPS valve non sterile (LN130B) Catalogue number Lot number Manufacturing date Expiry date LH130 RK11 2014.08.11 2017.07 LH130 RK20 2014.08.20 2017.07 LH130 RL02 2014.09.02 2017.08 LH130 RL08 2014.09.08 2017.08 LH130 RM20 2014.10.20 2017.09 LH130 RP08 2014.12.08 2017.11 LH130 TE27 2015.04.27 2018.03 LH130 TF08 2015.05.08 2018.04 LH130 TF14 2015.05.14 2018.04 LH130 TF21 2015.05.21 2018.04 LH130 TH06 2015.07.06 2018.06 LH130 TH16 2015.07.16 2018.06 LH130 TL21 2015.09.21 2018.08 LH130 TP14 2015.12.14 2018.11 LH130 UA11 2016.01.11 2018.12 LH130 UC08 2016.02.08 2019.01 LH130 UD14 2016.03.14 2019.02 LH130 UD28 2016.03.28 2019.02 LH130 UE05 2016.04.05 2019.03 LH130 UE18 2016.04.18 2019.03 LH130 UF09 2016.05.09 2019.04 LH130 UG06 2016.06.06 2019.05 LH130 UL12 2016.09.12 2019.08 LH130 UM10 2016.10.10 2019.09 LH130 VA02 2017.01.02 2019.12 LH130 VC06 2017.02.06 2020.01

Catalogue number Lot number Manufacturing date Expiry date LN130B RL15 2014.09.15 2017.08 LN130B RL22 2014.09.22 2017.08 LN130B RM27 2014.10.27 2017.09 LN130B RP01 2014.12.01 2017.10 LN130B RP22 2014.12.22 2017.11 LN130B TA12 2015.01.12 2017.12 LN130B TE17 2015.04.17 2018.03 LN130B TE20 2015.04.20 2018.03 LN130B TE22 2015.04.22 2018.03 LN130B TE23 2015.04.23 2018.03 LN130B TE24 2015.04.24 2018.03 LN130B TE25 2015.04.25 2018.03 LN130B TF01 2015.05.01 2018.03 LN130B TF04 2015.05.04 2018.04 LN130B TF06 2015.05.06 2018.04 LN130B TF07 2015.05.07 2018.04 LN130B TF08 2015.05.08 2018.04 LN130B TF15 2015.05.15 2018.04 LN130B TF18 2015.05.18 2018.04 LN130B TF19 2015.05.19 2018.04 LN130B TF20 2015.05.20 2018.04 LN130B TF21 2015.05.21 2018.04 LN130B TF30 2015.05.30 2018.04 LN130B TG01 2015.06.01 2018.04 LN130B TG04 2015.06.04 2018.05 LN130B TG05 2015.06.05 2018.05 LN130B TG08 2015.06.08 2018.05 LN130B TG12 2015.06.12 2018.05 LN130B TG15 2015.06.15 2018.05 LN130B TG16 2015.06.16 2018.05 LN130B TG17 2015.06.17 2018.05 LN130B TG19 2015.06.19 2018.05 LN130B TG22 2015.06.22 2018.05 LN130B TG23 2015.06.23 2018.05 LN130B TG24 2015.06.24 2018.05 LN130B TG25 2015.06.25 2018.05 LN130B TH06 2015.07.06 2018.06 LN130B TH07 2015.07.07 2018.06 LN130B TH08 2015.07.08 2018.06 LN130B TH09 2015.07.09 2018.06 LN130B TH10 2015.07.10 2018.06 LN130B TH13 2015.07.13 2018.06 LN130B TH15 2015.07.15 2018.06 LN130B TH17 2015.07.17 2018.06 LN130B TH31 2015.07.31 2018.06

Catalogue number Lot number Manufacturing date Expiry date LN130B TK03 2015.08.03 2018.07 LN130B TK04 2015.08.04 2018.07 LN130B TK06 2015.08.06 2018.07 LN130B TK07 2015.08.07 2018.07 LN130B TK10 2015.08.10 2018.07 LN130B TK12 2015.08.12 2018.07 LN130B TK14 2015.08.14 2018.07 LN130B TK17 2015.08.17 2018.07 LN130B TK18 2015.08.18 2018.07 LN130B TK24 2015.08.24 2018.07 LN130B TL23 2015.09.23 2018.08 LN130B TL25 2015.09.25 2018.08 LN130B TL28 2015.09.28 2018.08 LN130B TM01 2015.10.01 2018.08 LN130B TM05 2015.10.05 2018.09 LN130B TM07 2015.10.07 2018.09 LN130B TM09 2015.10.09 2018.09 LN130B TM23 2015.10.23 2018.09 LN130B TM26 2015.10.26 2018.09 LN130B TM28 2015.10.28 2018.09 LN130B TN02 2015.11.02 2018.10 LN130B TN05 2015.11.05 2018.10 LN130B TN19 2015.11.19 2018.10 LN130B TN23 2015.11.23 2018.10 LN130B TP01 2015.12.01 2018.10 LN130B UA04 2016.01.04 2018.12 LN130B UC01 2016.02.01 2018.12 LN130B UC29 2016.02.29 2019.01 LN130B UD07 2016.03.07 2019.02 LN130B UD21 2016.03.21 2019.02 LN130B UD28 2016.03.28 2019.02 LN130B UE04 2016.04.04 2019.03 LN130B UF23 2016.05.23 2019.04 LN130B UF31 2016.05.31 2019.04 LN130B UG20 2016.06.20 2019.05 LN130B UH18 2016.07.18 2019.06 LN130B UK29 2016.08.29 2019.07 LN130B UL12 2016.09.12 2019.08 LN130B UL19 2016.09.19 2019.08 LN130B UL26 2016.09.26 2019.08 LN130B UM17 2016.10.17 2019.09 LN130B UM24 2016.10.24 2019.09 LN130B UN28 2016.11.28 2019.10 LN130B UP12 2016.12.12 2019.11 LN130B VC13 2017.02.13 2020.01 LN130B VD20 2017.03.20 2020.02

Catalogue number Lot number Manufacturing date Expiry date LN130B VE03 2017.04.03 2020.03 LN130B VE24 2017.04.24 2020.03 LN130B VF15 2017.05.15 2020.04

FSCA 1702 - ANNEX II Involved lot numbers for Terumo Extracorporeal Sets containing OPS valve (LN130B) Catalogue number Lot number range CX AU038X 1602458 CX AU100X 1705327 CX AU101X 1608281 1608283 CX AU102X 1608111 CX BE062X 1508150 1610286 CX BE063X 1509358 1701295 CX BE066X 1508106 1610150 CX BE068X 1510018 1608444 CX BE069X 1509276 1704106 CX BE093X 1611202 1705265 CX BE094X 1701042 CX BL040X 1606021 1606024 CX BL047X 1606124 1608137 CX BL053X 1611260 1701165 CX CH034X 1510126 1512222 CX CH049X 1510305 1609149 CX CH062X 1602483 1611248 CX CH071X 1603149 CX CH088X 1703348 CX CH094X 1610337 1611032 CX CH096X 1610361 CX CH102X 1701331 1705165 CX CH105X 1702330 1705169 CX CR014 1609170 CX CY005 1703307 1704041 CX CY006 1703312 1704046 CX DB05 1610168 CX DB080 1509069 1706029 CX DB317X 1702327 1702328 CX DB318 1701086 CX DB319 1701088 CX DB320 1701160 CX DB321 1510176 1701205 CX DB329 1512152 1512153 CX DB334X 1702074 CX DB351X 1606012 1609221 CX DB379X 1602431 1701337 CX DB401X 1701278 CX DB407X 1705422 CX DB408X 1705420 CX DB409X 1705423 CX DB421X 1606113 1607201

Catalogue number Lot number range CX DB331X 1705419 1706076 CX DB336 1510309 CX DB337 1510310 CX DB338 1510308 CX DB387X 1601152 CX DB388X 1601153 CX DB404X 1603293 CX DB421X 1601420 1602345 CX DB459X 1705421 CX DB462 1511160 CX DB463 1511134 CX DB464 1602379 1701200 CX DB466 1606002 1609285 CX DB474X 1601427 CX DB475X 1601428 CX DB478 1601314 CX DB481X 1605397 CX DB483X 1605396 CX DB484X 1605395 CX DB497X 1603365 1705348 CX DB524 1608168 1701211 CX DK043 1601107 1604027 CX DK068 1508196 1704188 CX DK086 1511355 CX DK087 1511071 1604034 CX DK098 1512220 1612155 CX DK099 1511487 1701364 CX DK102 1608242 1706056 CX DK103 1611412 CX DK107 1703066 CX FAC01 1509335 1704166 CX FAC68 1607163 1702249 CX FR100 1508230 1602667 CX FR122 1508159 1511423 CX FR169 1508297 1512178 CX FR204X 1604266 1605351 CX FR221 1701207 1703013 CX FR222 1606373 1704191 CX GE092X 1508121 1706139 CX GE101 1508186 1702314 CX GE115X 1604265 CX GE134X 1508169 1705034 CX GE136 1509208 1702335 CX GE135 1508040 1703322 CX GE155 1608405 CX GE157 1508156 1603133

Catalogue number Lot number range CX GE157X 1604259 1702165 CX GE166X 1508295 1704056 CX GE173X 1508077 1705329 CX GE180 1509310 1706018 CX GE181X 1601312 1705414 CX GE193 1510130 1702017 CX GE195X 1509221 1704039 CX GE204X 1511060 1702010 CX GE211X 1602490 1604062 CX GE216X 1607434 CX GE218 1607383 1609381 CX GG005 1509148 1512015 CX GG006 1509306 1608008 CX GG009 1509346 1705159 CX GG012 1512016 1608235 CX GG016 1511441 1703131 CX GG038 1609057 1610015 CX GG039 1608244 1703189 CX GG041 1703190 CX GG042 1611349 CX GG045 1703354 CX GG046 1703353 CX IC002 1603257 CX IS019 1512012 1701174 CX IS021 1512237 1701173 CX IS022 1512014 1701176 CX IS039 1511097 1511100 CX IS041 1601096 1701171 CX IS055 1509228 1702053 CX IS057 1603163 1609313 CX IS061 1702107 CX IS062 1509019 1609087 CX IS071 1602333 1701339 CX IS082 1601310 1601388 CX IS083 1702196 CX IS088X 1705005 CX IS089X 1705006 CX IT090X 1703262 1705334 CX IT095X 1509168 1704075 CX IT096X 1509170 1705332 CX IT139X 1511211 1605168 CX IT160X 1608174 1705244 CX IT223X 1508331 1705206 CX IT226X 1508266 1705288 CX IT228X 1511263 1703319 CX IT246X 1509200 1704007

Catalogue number Lot number range CX IT254X 1510282 1705293 CX IT259X 1602273 1705015 CX IT290X 1606141 1705296 CX IT291X 1703285 1705339 CX IT292X 1703288 1705340 CX IT304X 1611345 1705301 CX IT305X 1704136 1704137 CX IT306 1702299 1705303 CX IT314X 1704132 CX NG002 1608016 CX PL083 1510298 1510326 CX QE12 1509183 1705051 CX QE4 1510037 1702179 CX ROCA 1508281 1702151 CX RU046 1511169 1705155 CX RU075 1612216 CX RU100 1509214 1705025 CX RU100X 1510260 1604246 CX RU101X 1508060 1705093 CX RU103 1510157 1705210 CX RU103X 1509223 1702202 CX RU124 1603427 1609168 CX RU125X 1603403 1705091 CX SA021X 1608332 CX SA022X 1608331 CX SA024X 1610041 CX SA030X 1612066 CX SA039X 1701222 CX SE013 1605061 1609320 CX SE030 1604247 CX SE037 1604248 CX SL009X 1509139 1705388 CX SL017X 1604010 1702007 CX SP022 1508172 1704103 CX SP034XC 1510317 1702320 CX SP049X 1509339 1704027 CX SP054A 1508191 1701143 CX SP054B 1508174 1703103 CX SP064 1511077 1603308 CX SP066XA 1509260 1510314 CX SP066XB 1508036 1703211 CX SP066XC 1609116 1704028 CX SP070 1508173 1704091 CX SP076A 1512235 1602425 CX SP076B 1603098 1703209 CX SP079 1509038 1702160

Catalogue number Lot number range CX SP091 1510073 1608045 CX SV055 1508086 1705007 CX SV056 1509345 1603090 CX SV059 1603006 1703321 CX SV065 1605189 1607372 CX SV072 1705124 CX SV073 1706016 1706089 CX TES014 1510047 1609305 CX UK224 1509377 1703242 CX UK325 1508065 1509238 CX UK343 1508113 1706274 CX UK352 1702048 1704102 CX UK371 1508070 1703114 CX UK437 1510161 1701045 CX UK440 1605183 CX UK448 1601401 1703206 CX UK460 1603084 CX UK467 1604263 CX UK484 1612197 1704158 CX UK486 1611187 CX UK487 1701183 CX UK488 1706078

SAFETY NOTICE This Safety Notice calls attention to a safety aspect of the Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve Attention: Chief of Perfusion; Director of Operating Room Services; Director of Biomedical Services; Risk Management Affected Product: Extracorporeal Tubing Set containing the Over-pressure Safety Valve Action: Advisory REASON FOR CORRECTION This Safety Notice calls attention to a situation that may arise with the LN130B over-pressure safety valve (OPS valve) within your Terumo Extracorporeal Tubing Set and recommends how to check to ensure the duckbill valve within the OPS valve is patent and allows flow through the valve. The valves are to prevent reversal of blood flow and the prevention of air embolism as well as limit excessive negative and positive pressure in the vent catheter. The OPS valve allows for flow in only one direction (from the catheter in the heart to the cardiotomy reservoir). WHAT TO DO NEXT Review this Safety Notice and follow the instructions in the Recommended Action section of this letter. If you have questions, contact your local Terumo representative. Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the OPS valve. Terumo CVS has received no reports of patient injury due to this issue. POTENTIAL HAZARD No flow through the duckbill valve within the OPS valve would prevent the ability to vent blood from the left ventricle, potentially resulting in distension of the ventricle. If the distension is prolonged, this may result in severe ventricular dysfunction. Terumo Cardiovascular Systems/ Terumo Europe N.V. Page 1 of 2 Safety Notice

RECOMMENDED ACTIONS Terumo CVS recommends that the customer test the valve in the tubing pack prior to use to ensure flow through the valve. 1. A member of the surgical team shall place the sterile end of the tubing with OPS valve in a basin of fluid on the sterile field and initiate pump flow to ensure flow through the valve. 2. If no fluid flow is evident through the duckbill valve after the test described above, maintain the tubing in the basin and place gloved fingers over the positive and negative umbrella relief valves (see diagram below). Turn on the roller pump at approximately 500 ml/minute and allow up to 30 seconds to create negative pressure on the duckbill valve to initiate fluid flow through the device. Once the duckbill is opened, it will operate as intended. Turn off roller pump. 3. If flow is still not observed, then we recommend removing the valve and replacing it with a single, sterile OPS valve. Please return the defective OPS valve to Terumo. 4. If you do not have a single, sterile OPS valve available, open a new Extracorporeal Tubing Set and use the line and OPS valve from it. CUSTOMER INSTRUCTIONS Review this Safety Notice and the Recommended Actions. Assure that all users receive notice of this issue. Test the OPS valve for flow prior to going on cardiopulmonary bypass by using the instructions provided in this letter. To return defective OPS valves, follow your complaint reporting protocol and contact Terumo. QUESTIONS? We encourage you to contact your local Terumo sales organization with any questions or concerns. REPORTING Any adverse event experienced with the use of this product, and/or quality problems shall immediately be reported to your local Terumo sales organization. Terumo Cardiovascular Systems/Terumo Europe N.V. Page 2 of 2 Safety Notice

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