Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

FDA Recall Z-0198-2016 · Posted 2015-11-02

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeMJC
Date Initiated2015-10-02
Date Terminated2016-08-01
Product Quantity4,170 each

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.

Firm Action

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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITRochester Medical Corp. · 2004-06-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑