Class 2 Device Recall Bard 100 LatexFree Urinary Drainage Bag with AntiReflux Chamber and Bard EXLok Sampling

• Date Initiated by Firm: January 30, 2015
• Date Posted: April 01, 2015
• Recall Status: Terminated on August 01, 2016
• Recall Number: Z-1358-2015
• Recall Event ID: 70666
• Product Classification: Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
• Product: Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
• Code Information: Lot Numbers NGYJ0603 and NGYJ1671
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: Sherry Saurini; 770-784-6119
• Manufacturer Reason for Recall: Potential breach of the sterile barrier packaging.
• FDA Determined Cause: Unknown/Undetermined by firm
• 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.
• Quantity in Commerce: 9,620 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.