FDA Recalls 222 Units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads
FDA is recalling 222 units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads due to a potential packaging defect that could compromise sterility and increase infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise and potential infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 222 units of the Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick. These medical devices are used with the Signia stapling system for various surgical procedures, including abdominal, gynecologic, pediatric, and thoracic surgeries. The specific product number is SIGTRSB60AMT.
The recall is issued because the packaging pouch may contain an extra laminate layer. This defect could compromise the sterility of the device. Additionally, the extra layer may prevent the complete removal of Ethylene Oxide sterilization gas, potentially increasing the risk of patient infection or exposure to retained Ethylene Oxide.
The affected units are distributed in Alabama, Arkansas, Florida, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, New York, Oregon, Pennsylvania, and Texas. The lot number is N0M0801RY, and the expiration date is 11/30/2023. Healthcare facilities and consumers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It…
- Manufacturer
- Covidien Llc
- Affected units
- 222
Distribution
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