Covidien recalls Tri-Staple 2.0 Reinforced Intelligent Reload 60mm staples for potential sterility compromise due to extra laminate layer, risking patient infection or ethylene oxide exposure.
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch
Covidien is recalling its Tri-Staple 2.0 Reinforced Intelligent Reload 60mm staples used in surgery. The recall is because the pouch might have an extra laminate layer, which could compromise sterility and increase infection risk or exposure to ethylene oxide gas.
The pouch may contain an extra laminate layer, which could compromise the device's sterility. This might lead to incomplete de-gassing of ethylene oxide sterilization gas, increasing the risk of patient infection or exposure to residual ethylene oxide.
Surgical teams using the Tri-Staple 2.0 Reinforced Intelligent Reload 60mm staples for abdominal, gynecologic, pediatric, or thoracic procedures. Patients undergoing surgery with these staples are at risk of infection or ethylene oxide exposure.
Check for product number SIGTRSB60AMT, lot number N0M0801RY, and expiration date 11/30/2023. The device is used with Signia stapling systems for specific surgical procedures.
Verify your product has the specific product number SIGTRSB60AMT, lot number N0M0801RY, and expiration date 11/30/2023.
The pouch may contain an extra laminate layer, which could compromise sterility and increase infection risk or ethylene oxide exposure.
The official recall notice does not specify a remedy or action steps beyond checking product details.
The recall indicates potential sterility issues, but the official notice does not state that the product is unsafe to use.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1419-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1419-2021 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.
