Z-1557-2021 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
- 10 cases (20 kits per case)
Product Description
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
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: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)