FDA Recall Terminated

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

Recall: Z-1358-2015 · Initiated January 30, 2015

Recall

Recall Number: Z-1358-2015
Event Number: 70666
Firm: C.R. Bard, Inc.
FEI Number: 1018233
Product Code: KNX
Status: Terminated
Root Cause: Unknown/Undetermined by firm
Initiated: January 30, 2015
Posted: April 1, 2015
Terminated: August 1, 2016
Address: 8195 Industrial Blvd Ne, Covington, GA, 30014-1497

Description

Reason

Potential breach of the sterile barrier packaging.

Action

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.

Distribution

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.

Quantity

9,620 units