Device product
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Z-1387-2023
Product summary
- Firm
- Covidien, LP
- Event
- Event 91873
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 770 units
- Official record key
device-enforcement:Z-1387-2023
Official wording
Reason: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Code information: GTIN: 10884521090767; Lot: P2G0069
Distribution pattern: Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
Derived failure modes
-
Unknown
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.