Recall Details
Medtronic Custom Perfusion kits, with the following product descriptions and correspondi ...
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);
Components:
Recall Date: Oct 12, 2021
Mfg:
Medtronic Perfusion Systems
Mfg Country:
United States
Recall ID: 88932
Product ID: 190057
Enforcement Date: Jan 19, 2022
Last Published: Jan 12, 2022
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RecallMe Number: Z-0491-2022
RecallMe Status: Notified
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