FDA Device recall Z-0292-2013
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc
- FDA Device
- Class I
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class I recall of ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc by Ethicon, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0292-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-21 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | PMA: P990004 Medical Device Listing Number: D100622 Product Code 2993 Lot/Batch Numbers: 239346 Exp Jan-13 239411 Exp Jun-13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2013%22
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