Z-1558-2021 Class I Terminated
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
- 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)