Z-1558-2021 Class I Terminated
FDA device recall Z-1558-2021 was initiated by Medical Action Industries, Inc. 306 on Apr 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 Oct 3, 2023). Affected quantity: 205 cases (20 kits per case).
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- Apr 9, 2021
- Termination Date
- Oct 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 205 cases (20 kits per case)
Product Description
Kit: Blood Culture. MAI Kit Part Number: 80315D
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: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1558-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026