Device product
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Z-1431-2021
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 87163
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,800 Units
- Official record key
device-enforcement:Z-1431-2021
Official wording
Reason: The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Code information: Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
Derived failure modes
-
Unknown
The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.