Kit: Central Line Dres Change 20/Cs
This recall has been terminated (originally issued September 8, 2021).
- Company
- Medical Action Industries Inc
- Recall Initiated
- September 8, 2021
- Terminated
- October 13, 2023
- Recall Number
- Z-0147-2022
- Quantity
- 42 cases
- Firm Location
- Arden, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Distribution
Distribution to a single US distributor in Michigan
Lot / Code Info
Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523
Root Cause
Process control
Action Taken
A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.