| Class 3 Device Recall Perfusion Tubing Pack | |
Date Initiated by Firm | February 04, 2016 |
Date Posted | February 26, 2016 |
Recall Status1 |
Terminated 3 on November 07, 2016 |
Recall Number | Z-1023-2016 |
Recall Event ID |
73261 |
510(K)Number | K012538 K891687 K924529 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
Product | 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 |
Code Information |
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 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00643169552869 TL7M46R7 209759903 00643169552869 TL7M46R9 210046775 00643169654587 TL8W39R2 09764959 00643169648906 TL8W39R3 209824083 00643169651654 TL8W39R3 209990175 00643169651654 |
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
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For Additional Information Contact | Lifeline Technical Support 877-526-7890 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Component design/selection |
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. |
Quantity in Commerce | 9890 (7773 US, 2117 OUS) |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DWF 510(K)s with Product Code = DWF 510(K)s with Product Code = DWF
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