Recall Z-0198-2016
C.R. Bard, Inc. · initiated October 2, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Codes / lots: Lot 53620131
Reason for recall
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0198-2016
- Initiated
- October 2, 2015
- Posted by FDA
- November 2, 2015
- Terminated
- August 1, 2016
- Product code
- MJC – Catheter, Urological (Antimicrobial) And Accessories
- Quantity
- 4,170 each
- Distribution
- Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
- Recalling firm
- C.R. Bard, Inc., Covington, GA