Z-1554-2021 Class I Terminated
FDA device recall Z-1554-2021 was initiated by Medical Action Industries, Inc. 306 on April 9, 2021 and is designated Class I. Reason for recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. The recall status is terminated (terminated October 3, 2023). Affected quantity: 30 cases (20 kits per case).
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- April 9, 2021
- Termination Date
- October 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 cases (20 kits per case)
Product Description
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Reason for Recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Distribution Pattern
Distributed US nationwide to OH, OR, FL and CA.
Code Information
Kit Number: 79420; UDI (GTIN): 20809160247775; Lot Number: 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022)