Reported Nov 28, 2012 · Terminated
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ…
Ethicon, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · US Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- 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.
- Lot codes and dates
- PMAP990004
- Medical Device Listing NumberD100622
- Product Code 2993 Lot/Batch Numbers239346 Exp Jan-13 239411 Exp Jun-13
- Amount recalled
- 28,276
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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