Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0292-2013 — 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, whe

U.S. FDA — Device Enforcement · United States · 2012-08-21 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0292-2013
Date of alert: 2012-08-21
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Ethicon, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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