ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
FDA Recall Z-0293-2013 · Posted 2012-11-16
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeLMF
Date Initiated2012-08-21
Date Terminated2014-09-11
Product Quantity45,200
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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