Recall Z-1358-2015
C.R. Bard, Inc. · initiated January 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Codes / lots: Lot Numbers NGYJ0603 and NGYJ1671
Reason for recall
Potential breach of the sterile barrier packaging.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-1358-2015
- Initiated
- January 30, 2015
- Posted by FDA
- April 1, 2015
- Terminated
- August 1, 2016
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Quantity
- 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.
- Recalling firm
- C.R. Bard, Inc., Covington, GA