Step Bladeless Trocars recall
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Why was Step Bladeless Trocars 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 10884521090767; Lot: P2G0069
- Product
- Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
- Recalling firm
- Covidien, LP
- Quantity
- 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.
- Recall date
- April 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)