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

FDA device recall Z-1358-2015 · posted 2015-04-01 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc.

Reason for recall

Potential breach of the sterile barrier packaging.

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

KNX

Quantity affected

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.

Date initiated

2015-01-30

Date posted

2015-04-01

Date terminated

2016-08-01

Location

Covington, GA