Z-0147-2022 Class II Terminated
FDA device recall Z-0147-2022 was initiated by Medical Action Industries, Inc. 306 on September 8, 2021 and is designated Class II. Reason for recall: The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. The recall status is terminated (terminated October 13, 2023). Affected quantity: 42 cases.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 8, 2021
- Termination Date
- October 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 cases
Product Description
Kit: Central Line Dres Change 20/Cs
Reason for Recall
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Distribution Pattern
Distribution to a single US distributor in Michigan
Code Information
Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523