Enforcement Report - Week of November 28, 2012
-
Back to Previous Page
Product Detail
| Product Description | ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery. |
|---|---|
| Recall Number | Z-0292-2013 |
| Classification | Class I |
| Code Info | PMA: P990004 Medical Device Listing Number: D100622 Product Code 2993 Lot/Batch Numbers: 239346 Exp Jan-13 239411 Exp Jun-13 |
| Product Distributed Qty | 28,276 |
| 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. |
Event Detail
| Event Id | 63322 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Ethicon, Inc. |
| City | Somerville |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union. |
-
