Z-2534-2021 Class II Ongoing
FDA device recall Z-2534-2021 was initiated by C.R. Bard Inc on August 5, 2021 and is designated Class II. Reason for recall: There is potential for packaging defects that may impact the sterile barrier. The recall status is ongoing. Affected quantity: 960 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 5, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 960 units
Product Description
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
Reason for Recall
There is potential for packaging defects that may impact the sterile barrier.
Distribution Pattern
US Nationwide distribution.
Code Information
Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(10)