Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994, manufactured by FERROSAN MEDICAL DEVICES A/S, was recalled due to potential temperature excursions between June 2021 and August 2021 affecting product effectiveness. All lots distributed from June 1-2, 2021 are affected.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 was recalled because it may have been exposed to temperatures outside the required range between June 2021 and August 2021, which could reduce its effectiveness. This affects surgical procedures where bleeding control is needed.
The kit may have been exposed to temperatures outside the required range during shipping from June 2021 to August 2021. This exposure could reduce the product's effectiveness in controlling bleeding during surgery, especially if the kit is used when the bleeding is not controlled by other methods.
Healthcare facilities that received the Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 between June 1 and June 2, 2021. Surgeons and medical staff using this kit for bleeding control in surgical procedures are most at risk.
Check for the product name 'Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994' and lot numbers 262801. The kit was distributed between June 1 and June 2, 2021.
Verify the product name and lot number to confirm if it matches the recalled items.
The kit may have been exposed to temperatures outside the required range between June 2021 and August 2021, which could reduce its effectiveness in controlling bleeding during surgery.
The risk is that the kit may not work as intended in controlling bleeding, especially in surgical procedures where other methods are ineffective or impractical.
Check for the product name 'Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994' and lot number 262801, which were distributed between June 1 and June 2, 2021.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1584-2022 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1584-2022 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
