Events

Recall of Device Recall Perfusion Tubing Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Perfusion Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73261
  • Event Risk Class
    Class 3
  • Event Number
    Z-1023-2016
  • Event Initiated Date
    2016-02-04
  • Event Date Posted
    2016-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143638
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Medtronic is notifying customers who have or may receive specific lots of medtronic perfusion tubing packs that include the potentially affected cuvettes manufactured by terumo cardiovascular systems (terumo cvs). terumo cardiovascular systems (terumo cvs) has distributed an urgent safety alert regarding the cd i¿ h/s cuvette. the cuvette is packaged into medtronic perfusion tubing packs and only sold as part of the pack.
  • Action
    Medtronic sent an Urgent Medical Device Safety Alert dated February 2016 to all consignees on February 4, 2016. The letter described the problem and the product involved in the recall. Advised consignees to review the Terumo CVS Urgent Safety Alert and follow the instructions in the Recommended Action Section of the Urgent Safety Alert letter. Requested consignees to completed the Customer Confirmation Certificate and Email completed form(s) to RS.CFQFCA@Medtronic.com. If email is not available, fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic representative or Lifeline Technical Support at 877-526-7890. For questions regarding this recall call 763-391-9000.

Device

Device Recall Perfusion Tubing Pack
  • Model / Serial
    Catalog No. Lot Number UPN / GTIN  BB8B09R4 209857492 00643169624436  BB8B09R4 210031260 00643169624436  BB8B09R4 210258522 00643169624436  BB8S23R 209685753 00643169624849  BB8S23R 209685754 00643169624849  BB8S23R 210141006 00643169624849  HY1W12R28 209821189 00643169620155  M273205G 210135065 00643169651258  M311110F 210007560 20643169409662  M311110F 210305334 20643169409662  M311110F 210646326 20643169409662  M311129K 210216215 00643169399280  M311129K 210637628 00643169399280  M311135D 210386285 00643169478183  M311136L 210100436 00643169515598  M311136L 210433599 00643169515598  M311151D 209903218 00643169475311  M321304B 210165927 20643169460694  M321709C 210129241 20643169636716  M322225D 210075636 00643169510203  M322225D 210175891 00643169510203  M322225D 210296690 00643169510203  M330119D 209872946 00643169583542  M331831E 210181103 00643169608412  M331831E 210322907 00643169608412  M334821J 210276579 00643169690967  M337503K 210300696 00643169490284  M338803C 210302285 00643169332539  M381004M 209998094 20643169299959  M381007B 209998093 20643169299942  M382206C 209998091 00643169480193  M421709C 210245944 00643169407367  M450202E 210093488 00643169648869  M450202E 210307287 00643169648869  M450311C 210143630 00643169617865  M450467K 210137624 00643169409781  M450467K 210188072 00643169409781  M450467K 210296689 00643169409781  M490753H 209918242 00643169472112  M490817B 210075633 00643169096271  M490817B 210513258 00643169096271  M491217D 210435629 00643169169197  M491546B 210006820 00643169415676  M491546B 210093491 00643169415676  M491547B 210254924 00643169415683  M491547B 210368459 00643169415683  M491908D 209930663 00643169655140  M494833B 209974536 00643169620087  M494833B 210099871 00643169620087  M494833C 210277621 00643169692589  M497549H 210112884 20643169588503  M497549H 210364073 20643169588503  M498408B 210093495 00643169640375  M499216B 209807154 00643169540866  M499709D 209974535 00643169348981  M612501C 210283502 00643169656901 1M66R1 210224823 00885074019369 1N16R19 209674468 00613994642028 1N16R19 209674469 00613994642028 1N16R19 209789389 00613994642028 1N16R19 210010537 00613994642028 1N16R19 210010538 00613994642028 1N16R19 210084995 00613994642028 1N16R19 210085738 00613994642028 1N16R19 210160297 00613994642028 1N16R19 210162743 00613994642028 1N16R19 210162744 00613994642028 2R88R3 209857551 00613994462732 2R88R3 210140927 00613994462732 5B54R3 209857561 00613994397959 5G80R6 209948268 00643169578531 5J39R30 209784926 00643169649156 5J39R30 209922891 00643169649156 5J39R30 210204096 00643169649156 6A30R1 209980203 00643169409538 6T40R6 209968093 00613994993083 6T40R6 209968189 00613994993083 6X37R6 210224830 00643169188983 7T88R 210300649 00643169276734 7Y17R1 209702296 00643169362840 8J59R 210046473 00643169485341 8J59R1 210219866 00643169673618 8J83R3 210224829 00643169673588 BB2N37R9 209646278 00643169534452 BB2N37R9 209857611 00643169534452 BB2N37R9 210079510 00643169534452 BB3M00R24 209646296 00643169494176 BB3M00R25 209857524 00643169652286 BB3M00R25 210238215 00643169652286 BB5G58R30 209674453 00643169506152 BB5P51R17 209732303 00643169632370 BB5P51R17 209948931 00643169632370 BB6M22R11 209674508 00643169473379 BB6M22R11 210010520 00643169473379 BB6M99R11 209857529 00643169652279 BB6U40R11 209674466 00643169449442 BB6U40R11 209922681 00643169449442 BB6U40R11 209923081 00643169449442 BB6U81R2 2 09720186 00643169518278 BB7L41R19 209641915 00643169594128 BB7L41R19 210079527 00643169594128 BB7N95R16 209731582 00643169574601 BB7N95R16 209986666 00643169574601 BB7N95R16 210107064 00643169574601 BB7P34R5 209759904 00643169381018 BB7P34R5 210174834 00643169381018 BB7P41R5 209732209 00643169380950 BB7P46R4 210377567 00643169380967 BB7P48R4 209674436 00643169379848 BB7P48R4 210010572 00643169379848 BB7P48R4 210305948 00643169379848 BB7Q35R11 209732227 00643169398818 BB7V76R 210140914 00643169505698 BB7V77R 210187624 00643169505681 BB7W39R11 21007951 4 00643169663091 BB7W39R11 210187625 00643169663091 BB7W39R9 209641909 00643169628465 BB7W39R9 209893126 00643169628465 BB7W39R9 209893127 00643169628465 BB7Y32R12 209759922 00643169486768 BB8A03R6 209821252 00643169486539 BB8A47R3 209789373 00643169582996 BB8A47R3 209981564 00643169582996 BB8A55R5 210046773 00643169663077 BB8A55R5 210305654 00643169663077 BB8A69R8 209948930 00643169510234 BB8B09R4 209590476 00643169624436 BB8B13R6 209621287 00643169619265 BB8B13R6 209789392 00643169619265 BB8B13R6 210079467 00643169619265 BB8B70R7 209981427 00643169622715 BB8D13R10 209758199 00643169641440 BB8D13R10 209917013 00643169641440 BB8D13R11 210140904 00643169668768 BB8D13R11 210174881 00643169668768 BB8D40R3 209943589 00643169655461 BB8D43R3 209789256 00643169647145 BB8D43R3 210106708 00643169647145 BB8D43R3 210174919 00643169647145 BB8D73R 210102442 00643169433168 BB8F81R 209759889 00643169467002 BB8F81R 209922884 00643169467002 BB8F81R 210107120 00643169467002 BB8F81R1 210174827 00643169670679 BB8F82R1 210079462 00643169502574 BB8F82R1 209621273 00643169502574 BB8G43R1 209732297 00643169479661 BB8J66R10 209710304 00643169632288 BB8J66R11 209948416 00643169657755 BB8J66R11 209948417 00643169657755 BB8J66R11 209948418 00643169657755 BB8J66R11 210096212 00643169657755 BB8L35R 209810631 20643169486779 BB8L35R1 209871098 20643169653447 BB8L35R1 210305692 20643169653447 BB8L58R3 209674434 00643169552852 BB8L58R3 209938451 00643169552852 BB8M48R2 209704350 00643169531307 BB8M48R2 209857613 00643169531307 BB8M48R2 210046776 00643169531307 BB8N70R4 209697471 00643169640764 BB8P69R 209986634 00643169566491 BB8S37R4 210036786 00643169660526 BB8S74R2 209690217 00643169640030 BB8S74R3 209927776 00643169655454 BB8T05R1 209754147 00643169631649 BB8T05R1 209755028 00643169631649 BB8T51R2 209826519 00643169652262 BB8T80R1 210140963 00643169620773 BB8X08R 209871092 20643169653478 BB8X09R2 210005980 00643169658158 CB0M02R5 209910888 00613994294692 CB0M02R5 210162397 00613994294692 CB1Y08R30 209866994 00643169609754 CB1Y08R30 209866995 00643169609754 CB1Y08R30 209866996 00643169609754 CB1Y08R30 209915338 00643169609754 CB1Y08R30 209915339 00643169609754 CB2E37R24 209646029 00643169543546 CB2E37R24 209809077 00643169543546 CB2E37R24 209916217 00643169543546 CB2E37R24 209916218 00643169543546 CB2E37R24 209946701 00643169543546 CB2E37R24 210036174 00643169543546 CB2E37R24 210079555 00643169543546 CB2E37R24 210138340 00643169543546 CB2E68R6 209985726 00613994596390 CB2W45R17 209759930 00643169546004 CB2W45R17 210162745 00643169546004 CB2W45R17 210174860 00643169546004 CB3Z71R12 209848391 00643169571730 CB4800R18 21007945 8 00613994534545 CB4800R18 210174900 00613994534545 CB4958R16 210046408 00613994534552 CB4L56R23 210160590 00643169578616 CB4N63R14 209821152 00643169346291 CB4N63R14 210204024 00643169346291 CB4W67R15 209732266 00643169602762 CB4W67R15 209871095 00643169602762 CB4W67R15 210010517 00643169602762 CB4Z27R 210174817 00613994250964 CB5A30R11 209821196 00643169505308 CB5A30R11 210107097 00643169505308 CB5D50R2 209731593 00643169448049 CB5D50R2 209789247 00643169448049 CB5D50R2 210305519 00643169448049 CB5P36R10 209821205 00643169569553 CB5V89R5 210237478 00643169665897 CB5X49R17 209922931 00643169427433 CB5X49R17 210168501 00643169427433 CB6C24R12 209710179 00643169523302 CB6M65R 209704260 00613994923264 CB6M65R 210106713 00613994923264 CB6M65R 210267432 00613994720351 CB6V11R9 209821197 00643169366770 CB6V11R9 210305888 00643169366770 CB6Z18R3 210204060 00643169098121 CB6Z60R7 209704358 20643169505296 CB6Z60R7 209759872 20643169505296 CB6Z60R7 210079511 20643169505296 CB6Z60R7 210204117 20643169505296 CB6Z60R7 210305898 20643169505296 CB7D52R 209981420 00643169046634 CB7E31R11 210377545 00643169617421 CB7F11R9 209732198 00643169534025 CB7F11R9 209821192 00643169534025 CB7F11R9 210174869 00643169534025 CB7F11R9 210238181 00643169534025 CB7J45R2 209956456 00643169158238 CB7J97R5 209789338 00643169531390 CB7J97R5 210377461 00643169531390 CB7J97R8 210204057 00643169641228 CB7J97R8 210341807 00643169641228 CB7J98R7 210203990 00643169640870 CB7M84R3 209893064 00643169485235 CB7M84R3 210107041 00643169485235 CB7M84R3 21016850 3 00643169485235 CB7N42R7 209668822 00643169639096 CB7N42R7 209668823 00643169639096 CB7N42R7 209668824 00643169639096 CB7N42R7 209668825 00643169639096 CB7N42R7 209668826 00643169639096 CB7N42R7 209668827 00643169639096 CB7N42R7 209668828 00643169639096 CB7N42R7 209668829 00643169639096 CB7N42R7 209699218 00643169639096 CB7N42R7 209809426 00643169639096 CB7N42R7 209809427 00643169639096 CB7N42R7 209809429 00643169639096 CB7N52R 210102454 00643169343719 CB7N52R 210266779 00643169343719 CB7N52R 210333570 00643169343719 CB7N54R1 210230715 00643169343726 CB7P87R9 210370463 00643169316867 CB7U79R9 209789343 00643169555518 CB7U79R9 210140699 00643169555518 CB7U79R9 210238180 00643169555518 CB7W53R1 210370420 00643169370951 CB7X82R4 209759901 00643169471986 CB7X82R4 209945892 00643169471986 CB7X88R8 209704289 00643169503489 CB7Z19R12 209809075 00643169632769 CB8A17R1 210140986 00643169591233 CB8G67R4 209673526 00643169639478 CB8G67R5 210093640 00643169662759 CB8G67R5 210093641 00643169662759 CB8G67R5 210093643 00643169662759 CB8G67R5 210093644 00643169662759 CB8L67R 209857585 00643169511002 CB8L67R 209961591 00643169511002 CB8L67R1 210204050 00643169671324 CB8L68R1 209590561 00643169572928 CB8L68R1 209821242 00643169572928 CB8L68R1 210010536 00643169572928 CB8Q44R2 209890932 00643169654457 CB8Q44R2 210102397 00643169654457 CB8U31R1 20987108 9 00643169625426 HY0L44R20 209948033 00643169513266 HY0Z20R21 209857521 00643169463356 HY0Z20R21 209981152 00643169463356 HY0Z20R21 210238122 00643169463356 HY1C33R26 210010580 00643169462304 HY1C33R26 210238185 00643169462304 HY2800R37 209981429 00643169464803 HY2800R37 210238124 00643169464803 HY2J35R12 209674416 00643169476325 HY2J36R13 209759925 00643169464810 HY2J36R13 210107121 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE, NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI. Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.
  • Product Description
    Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. || Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. || This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Manufacturer Address
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA