Covidien recalls 30 Violet Absorbable Tacks for potential sterility breach due to packaging issues. Affected units may compromise surgical product safety.
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Covidien is recalling 30-violet absorbable tacks used in hernia repairs because their packaging might allow moisture and contamination to reach the product, risking infection during surgery. This is a serious safety issue for patients undergoing surgical procedures.
The packaging may not seal properly, allowing moisture and contaminants to enter the sterile pouch. This could compromise the product's sterility during surgery, potentially causing infections in patients.
Surgical patients and healthcare providers using the AbsorbaT: 30 Violet Absorbable Tacks for hernia repairs. Those with the specific model (ABSTACK30) or lot number (N3J1860Y) are most at risk.
Check for the model number ABSTACK30 on the packaging or the lot number N3J1860Y. The product is intended for hernia repair procedures and sold with a GTIN of 20884523006527.
Immediately stop using the AbsorbaTack tacks if you have the model ABSTACK30 or lot number N3J1860Y.
The packaging may have a low seal strength, potentially causing a sterile/moisture barrier breach that could compromise the product's sterility during surgery.
The model number is ABSTACK30, with lot number N3J1860Y.
The recall does not provide a fix; the remedy is null, meaning users must stop using the product immediately.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0986-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0986-2024 from Covidien. 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.
