Z-1431-2021 Class II Terminated
FDA device recall Z-1431-2021 was initiated by C.R. Bard, Inc. on January 11, 2021 and is designated Class II. Reason for recall: The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. The recall status is terminated (terminated February 2, 2023). Affected quantity: 9,800 Units.
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- January 11, 2021
- Termination Date
- February 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,800 Units
Product Description
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Reason for Recall
The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
Code Information
Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024