—#134365

Product

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671

FDA product code: KNX — Collector, Urine, (And Accessories) For Indwelling Catheter
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot Numbers NGYJ0603 and NGYJ1671

Why it was recalled

Potential breach of the sterile barrier packaging.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Bard sent an Urgent Medical Device Recall letter on January 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter also requested that a sub-recall should be conducted if the product was further distributed. The letter also included a response form which is to be returned to Bard. This voluntary recall is only for the lots noted above with the affected product catalog number. Notifications of this recall are being sent to all affected accounts of Bard Medical Division, Inc. If you have further distributed this product, you are required to notify your accounts of the voluntary recall. If you have any questions or need assistance in notifying your accounts about the correction, please call 1-770-784-6471. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.

Timeline

Recall initiated: 2015-01-30
Posted by FDA: 2015-04-01
Terminated: 2016-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134365. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.