Device product
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
Z-1556-2021
Product summary
- Event
- Event 87722
- Status
- Terminated
- Classification
- Class I
- Quantity
- 110 cases (5 kits per case)
- Official record key
device-enforcement:Z-1556-2021
Official wording
Reason: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Code information: Kit Number: 77981B; UDI (GTIN): 20809160284053; Lot Number: 0000281502 (Expiration Date: 04/08/2022), 0000282039 (Expiration Date: 04/08/2022), 0000274390 (Expiration Date: 07/09/2021), and 0000279101 (Expiration Date: 11/13/2021)
Distribution pattern: Distributed US nationwide to OH, OR, FL and CA.
Derived failure modes
-
Unknown
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.