Recalls / —
—#140928
Product
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
- FDA product code
- MJC — Catheter, Urological (Antimicrobial) And Accessories
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K033477
- Affected lot / code info
- Lot 53620131
Why it was recalled
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Root cause (FDA determination)
Error in labeling
Action the firm took
Bard sent a Customer Notification Letter dated September 29 to customers via FedEx with proof of delivery notice. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to carry out the notification to the user level. Customers with questions were instructed to contact BMD at 1-770-784-6471.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
Timeline
- Recall initiated
- 2015-10-02
- Posted by FDA
- 2015-11-02
- Terminated
- 2016-08-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #140928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.