FDA recall Z-0147-2022
Medical Action Industries, Inc. 306 · Class II · device
Product
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
Distribution to a single US distributor in Michigan
Key facts
- Status
- Terminated
- Initiation date
- 2021-09-08
- Report date
- 2021-10-27
- Termination date
- 2023-10-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Arden, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2022