Device product
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Z-1636-2018
Product summary
- Firm
- Vygon U.S.A.
- Event
- Event 79752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16520 total products
- Official record key
device-enforcement:Z-1636-2018
Official wording
Reason: Potential friction holes may affect the sterility of the product.
Code information: Lot Numbers: 17F001D & 17K038D UDI: 08498840004814
Distribution pattern: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Derived failure modes
-
Unknown
Potential friction holes may affect the sterility of the product.