Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are so

FDA device recall Z-2327-2012 · posted 2012-09-07 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc., Urological Division

Reason for recall

Incomplete seal on sterile packages of product.

Action taken

C. R. Bard Inc, sent a Urgent Product Recall Notification letter dated June 27. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notification is being sent because there is a potential for a limited number of units within the subject lots (noted above) that may contain an open seal of the sterile packages. The issue is visually obvious even before the package is opened. No patient injury or adverse events have been reported. Do not use or further distribute any of the affected products. Once the product affected by tlle recall has been removed from your inventory 1.Fill out the Recall & Effectiveness Check Form. Be sure to state the quantities affected of the recalled product that you have in stock. It is extremely important that we receive this information. 2. Fax the Recall & Effectiveness Check Form to BMD at 1-770-784-6469. The Recall Coordinator will issue you with a Return Authorization (RCL) to facilitate the expedient return and replacement of the product. 3. A mailing label is enclosed for your convenience to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and include the RCL number. All products should be retumed to the following shipping address that is in the letter.

Root cause

Process control

Status

Terminated

Product code

EZC

Quantity affected

56,694 units

Distribution

Nationwide distribution: USA

Date initiated

2012-06-29

Date posted

2012-09-07

Date terminated

2013-02-07

Location

Covington, GA