FDA Device recall Z-0293-2013
ETHICON SURGIFLO HEMOSTATIC MATRIX 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 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-0293-2013 |
| 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 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.
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 number P990004 Medical Device Listing Number D100622 Product Code: 2991 Lot # 239091 Exp Mar-13 Lo…PMA number P990004 Medical Device Listing Number D100622 Product Code: 2991 Lot # 239091 Exp Mar-13 Lot # 238783 Exp Sep-13 Lot # 238635 Exp Mar-13 Lot # 237498 Exp Mar-13 Lot # 237119 Exp Mar-13 Lot # 235488 Exp Jan-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-0293-2013%22
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