ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 088

FDA device recall Z-0292-2013 · posted 2012-11-16 · Terminated

Recall details

Recalling firm

Ethicon, Inc.

Reason for recall

SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.

Action taken

Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory to determine if they have any of the affected product. Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label. Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative. For questions regarding this recall call 877-384-4266.

Root cause

Packaging

Status

Terminated

Product code

LMF

Quantity affected

28,276

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.

Date initiated

2012-08-21

Date posted

2012-11-16

Date terminated

2014-09-11

Location

Somerville, NJ