Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 0

FDA device recall Z-1897-2012 · posted 2012-06-27 · Terminated

Recall details

Recalling firm

Ethicon, Inc.

Reason for recall

The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process.

Action taken

Ethicon Inc. sent a Urgent Voluntary Product Recall letter dated April 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you have any product subject to this voluntary recall, please remove it from your inventory immediately and return it per the following instructions. Return product to Stericycle using the enclosed pre-paid shipping label. Shipping fees wil be charged directly to Ethicon through the use of this shipping label. No reimbursements will be made for the shipping charge if this label is not used. Extra shipping labels may be obtained by calling 1-866-338-2611. Credit will be issued for impacted product that is returned. Further questions please call 1-866-338-2611, or contact your Ethicon Biosurgery Sales Representative. Thank you for your coorporation and immediate assistance. .

Root cause

Packaging process control

Status

Terminated

Product code

LMF

Quantity affected

27,396 kits

Distribution

USA (nationwide)

Date initiated

2012-04-03

Date posted

2012-06-27

Date terminated

2014-04-16

Location

Somerville, NJ