Recall record at a glance
| Official record | Z-1419-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Covidien LLC |
| Report date | Apr 21, 2021 |
| Recall initiation date | Mar 23, 2021 |
| Quantity | 222 units |
| Location | Mansfield, MA, United States |
Official product description
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 may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. Product Number: SIGTRSB60AMT
Why the product was recalled
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
Distribution information
AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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