Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Perfusion Tubing Packs

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Medtronic Perfusion Tubing Packs see related information
Date Initiated by Firm October 12, 2021
Create Date January 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-0491-2022
Recall Event ID 88932
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers:

1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R);

2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R);

3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22);

4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25);

5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22);

6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4);

7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4);

8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8);

9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7);

10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7);

11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8);

12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3);

13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R);

14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8);

15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33);

16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17);

17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18);

18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24);

19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12);

20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7);

21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6);

22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6);

23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1);

24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4);

25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4);

26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6);

27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4);

28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12);

29. PERFUSION M337112Q 1/B (Model M337112Q);

30. PERFUSION M344130B 1/B (Model M344130B);

31. PERFUSION M392419C 1/B (Model M392419C);

32. PERFUSION M394213B 1/B (Model M394213B);

33. PERFUSION M394213C 1/B (Model M394213C);

34. PERFUSION M490124D 1/B (Model M490124D);

35. PERFUSION M491335A 1/B (Model M491335A);

36. PERFUSION M499709E 1/B (Model M499709E);

37. PERFUSION M960164F 1/B (Model M960164F);

38. PERFUSION M960165E 1/B (Model M960165E);

39. PERFUSION M960169E 1/B (Model M960169E);

40. PERFUSION M960462C 1/B (Model M960462C);

41. PERFUSION M960462D 1/B (Model M960462D);

42. PERFUSION M960463D 1/B (Model M960463D);

43. PERFUSION M960466D 1/B (Model M960466D);

44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3);

45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12);

46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5);

47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9);

48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);


Code Information Medtronic Perfusion Kits: 1. Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) GTIN 20763000343068, Lot Numbers: 219822381, 220104257 2. Model BB11C01R, GTIN 00763000312190, Lot Numbers: 218556144, 218790882, 219012584, 219586019 3. Model B7H95R22, GTIN 00763000250904, Lot Numbers: 219586008, 220075503, 220476338 4. Model BB7H95R25, GTIN 00763000451738, Lot Numbers: 221406421 5. Model BB7H99R22, GTIN 00763000250911, Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 6. Model BB7P46R4, GTIN 00643169380967, Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 7. Model BB7P48R4, GTIN 00643169379848, Lot Numbers: 219073386 8. Model BB7W03R8, GTIN 00643169990562, Lot Numbers: 219107651, 219491297, 221590546 9. Model BB7W80R7, GTIN 00763000344535, Lot Numbers: 219380830, 219600017, 222304697, 222400044 10. Model BB8B09R7, GTIN 00763000307189, Lot Numbers: 218613111 11. Model BB8B09R8, GTIN 00763000347574, Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 12. Model BB8D40R3, GTIN 00643169655461, Lot Numbers: 219220652, 219482298 13. Model BB8Q16R, GTIN 00643169549364, Lot Numbers: 218657286, 221451556 14. Model BB8V01R8, GTIN 00763000411312, Lot Numbers: 221267645 15. Model HY2V10R33, GTIN 00763000299835, Lot Numbers: 219165752, 220104314 16. Model HY3Z71R17, GTIN 00763000241551, Lot Numbers: 219073460 17. Model HY3Z71R18, GTIN 00763000353728, Lot Numbers: 219435852, 220219913, 220911962 18. Model HY4V00R24, GTIN 00763000082451, Lot Numbers: 219115980, 219436006, 219975242, 220383867 19. Model HY6X29R12, GTIN 00763000280833, Lot Numbers: 218912023, 219061258, 219061259, 219061260, 219390708, 220075525, 220075526, 220281424, 220434431 20. Model HY8L14R7, GTIN 00763000353360, Lot Numbers: 220075494 21. Model HY8P36R6, GTIN 00763000097165. Lot Numbers: 219291532 22. Model HY8V01R6, GTIN 00763000025465, Lot Numbers: 218557263, 218901885 23. Model HY9D36R1, GTIN 00643169855465, Lot Numbers: 219291881, 219291882, 219291883, 219682010, 220144062, 220144063, 220383952, 220383953, 220383954 24. Model HY9L07R4, GTIN 00763000093495, Lot Numbers: 219237962 25. Model HY9L80R4, GTIN 00763000092603, Lot Numbers: 220104289 26. Model HY9M47R6, GTIN 00763000175634, Lot Numbers: 219165837, 219165838, 219452417, 219452418, 220295056, 220295059 27. Model HY9N38R4, GTIN 00643169985148, Lot Numbers: 219061189, 219390629, 220383876, 220954138 28. Model HY9R26R12, GTIN 00763000317942, Lot Numbers: 218790663, 219343932, 219401495, 220337254, 220866450, 220866451 29. Model M337112Q, GTIN 00763000242824, Lot Numbers: 219983643, 219984266, 221053657, 221206757, 221452447, 221516971 30. Model M344130B, GTIN 00643169946415, Lot Numbers: 218419494, 218419495, 220815603, 220883905, 221971754 31. Model M392419C, GTIN 00763000343095, Lot Numbers: 219179139, 220224289, 220637117, 221383886 32. Model M394213B, GTIN 00643169546417, Lot Numbers: 218544365, 218544407 33. Model M394213C, GTIN 00763000446437, Lot Numbers: 221309293, 222084799 34. Model M490124D, GTIN 00763000527471, Lot Numbers: 222060635 35. Model M491335A, GTIN 00763000372187, Lot Numbers: 219712665, 220479358 36. Model M499709E, GTIN 00643169713420, Lot Numbers: 219495811 37. Model M960164F, GTIN 00763000300128, Lot Numbers: 218616224, 218616225, 219868444, 22280711 38. Model M960165E, GTIN 00763000139445, Lot Numbers: 218551983, 218728458, 218728459, 222107381 39. Model M960169E, GTIN 00763000139421, Lot Numbers: 218517966, 220900240, 222047414, 222410763 40. Model M960462C, GTIN 00643169957015, Lot Numbers: 218953465 41. Model M960462D, GTIN 00763000399344, Lot Numbers: 220172291 42. Model M960463D, GTIN 00763000234775. Lot Numbers: 218483662, 218517778, 218742946, 218742949, 220729353, 220801827, 220867180, 220950181, 221143520, 221618074, 221875985 43. Model M960466D, GTIN 00763000090494, Lot Numbers: 219874178 44. Model TL4K33R3, GTIN 00613994288622, Lot Numbers: 220197637 45. Model TL4K95R12, GTIN 00763000247867, Lot Numbers: 219061229, 220383926 46. Model TL6C91R5, GTIN 00643169343641, Lot Numbers: 219435870 47. Model TL6G48R9, GTIN 00763000367909, Lot Numbers: 220004241, 220004242, 220326313, 220911952, 220911998 48. Model TL7X09R3, GTIN 00643169455115, Lot Numbers: 219107641, 219107642, 221000547
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		 Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic began notifying customers on 10/18/2021, via 2-day UPS delivery, with letter titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to review inventory for affected Medtronic Perfusion Tubing Packs, identify and quarantine any affected product found in inventory, return any affected product on hand by contacting Customer Service at 1-800-854-3570, Option1 then Option 4, and referencing this communication to initiate a return and credit of unused product. Additionally, customers were instructed to complete the enclosed Customer Confirmation Certificate and scan and email to RS.CFQFCA@medtronic.com. This form must be returned even if there is no affected Perfusion Tubing Packs in inventory. Customers were also requested to share the notification with others in your organization as appropriate. If product within scope of this Urgent Medical Device Recall has been forwarded to another facility, please notify the facility of the Medtronic Urgent Medical Device Recall.
Quantity in Commerce 6,653 units
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The countries of Canada, Columbia, France, Germany, Italy, Netherlands, Saudi Arabia, Spain.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-