Z-1542-2021 Class II Terminated
FDA device recall Z-1542-2021 was initiated by ROi CPS LLC on March 26, 2021 and is designated Class II. Reason for recall: ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity. The recall status is terminated (terminated January 30, 2023). Affected quantity: 272 trays.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- January 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 272 trays
Product Description
Regard Dressing Change Tray
Reason for Recall
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Distribution Pattern
US Nationwide distribution in the state of Louisiana.
Code Information
Lot Numbers: 86983C, 87081C and 86356C.