Recall Z-0667-2022
C.R. Bard Inc · initiated January 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Codes / lots: Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)
Reason for recall
There is a potential to leak from the catheter where it connects to the drain bag
FDA-determined cause: Under Investigation by firm
Action taken
The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.
Details
- Recall number
- Z-0667-2022
- Initiated
- January 27, 2022
- Terminated
- July 10, 2026
- Product code
- KOD – Catheter, Urological
- Quantity
- 1620 units
- Distribution
- US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
- Recalling firm
- C.R. Bard Inc, Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0666-2022 Class II | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14CThere is a potential to leak from the catheter where it connects to the drain bag | 01/27/2022Terminated |