Device product
CATHETER SECUREMENT SYSTEM
Z-1083-2018
Product summary
- Event
- Event 79329
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1083-2018
Official wording
Reason: Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Code information: CSS490 Lot codes: 2016022290 2017071790
Distribution pattern: Nationally
Derived failure modes
-
Unknown
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.