Z-2529-2021 Class II Ongoing
FDA device recall Z-2529-2021 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: 2660 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
- 2660 units
Product Description
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Reason for Recall
There is potential for packaging defects that may impact the sterile barrier.
Distribution Pattern
US Nationwide distribution.
Code Information
Catalog A800061, Lot NGFR3658, UDI (01)00801741104848(17)251228(10)