LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 c

FDA device recall Z-0178-2012 · posted 2011-11-09 · Terminated

Recall details

Recalling firm

LifeCell Corporation

Reason for recall

The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.

Action taken

LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August 17, 2011. Questions should be directed to Customer Solutions at 1-866-423-2433.

Root cause

PMA

Status

Terminated

Product code

FTM

Quantity affected

2651 sublots (of 42 lots)

Distribution

Nationwide Distribution

Date initiated

2011-07-13

Date posted

2011-11-09

Date terminated

2013-03-04

Location

Branchburg, NJ

Related 510(k) clearances