Recall StatusTerminated
Date Initiated2015-01-30
Date Terminated2016-08-01
Product Quantity9,620 units
Reason for Recall
Potential breach of the sterile barrier packaging.
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.
Root Cause
Unknown/Undetermined by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.