Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208

FDA device recall Z-0526-06 · posted 2006-02-22 · Completed

Recall details

Recalling firm

Davol, Inc., Sub. C. R. Bard, Inc.

Reason for recall

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

Action taken

Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots. On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery.

Root cause

Other

Status

Completed

Product code

FTL

Quantity affected

31,761 units

Distribution

Nationwide Foreign: Australia, Canada, Japan,

Date initiated

2005-12-22

Date posted

2006-02-22

Location

Cranston, RI