FDA Enforcement
Class II
Ongoing
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Recall: Z-0110-2024
·
Reported October 18, 2023
Enforcement
- Recall Number
- Z-0110-2024
- Event ID
- 93097
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 18, 2023
- Initiation Date
- September 12, 2023
- Classification Date
- October 12, 2023
- Address
- 7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States
Description
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Reason
Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.
Code Info
UDI-DI: 038290HXRPGWNNMN; Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488
Distribution
Worldwide - US Nationwide distribution.
Quantity
781,600 vials