Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Reported: April 19, 2023 Initiated: March 1, 2023 #Z-1387-2023
Product Description
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Reason for Recall
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.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 770 units
- Distribution
- 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.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010. Recalled by Covidien, LP. Units affected: 770 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1387-2023.
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