Recalls / —
—#185461
Product
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
- FDA product code
- KOD — Catheter, Urological
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K802665
- Affected lot / code info
- Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024
Why it was recalled
The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Root cause (FDA determination)
Packaging process control
Action the firm took
All customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
Timeline
- Recall initiated
- 2021-01-11
- Terminated
- 2023-02-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #185461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.