Step Bladeless Trocars recalled for sterilization failure
Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. However, unsterile surgical instruments pose a serious potential hazard including infection risk and potential vision loss in ophthalmic applications, meeting the criterion for high-severity risk-of-harm where injury has not been reported.
Plain-English summary
Covidien, LP is recalling 770 units of Step Bladeless Trocars, Model S101010 (Lot P2G0069). The instruments were distributed worldwide following a sterilization process failure.
A supplier calibration issue during contract sterilization may have resulted in unsterile product. Use of unsterile surgical instruments could lead to infection. In ophthalmic applications, there is also a potential risk of vision loss.
The affected units were distributed to multiple U.S. states including Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio, and Washington, as well as internationally to Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
The recalled product
- Product
- Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
- Manufacturer
- Covidien, LP
- Affected units
- 770
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 10884521090767
- Lot: P2G0069
Distribution
Part of a larger recall action
This product is one of 4 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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