FDA-Device2023-04-19Class II
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Covidien, LP
Hazard
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.
Sold states
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.
Affected count
770 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief