Device product
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Z-1030-2015
Product summary
- Event
- Event 70313
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4484
- Official record key
device-enforcement:Z-1030-2015
Official wording
Reason: Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Code information: Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS, ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A, ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A , CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120
Distribution pattern: US (nationwide) and PR.
Derived failure modes
-
Unknown
Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.