Stryker Neptune E-SEP Blade Electrode Recalled for Expired Product
Stryker is recalling 40 units of Neptune E-SEP 165mm Blade Electrodes shipped to Canada because they were expired due to a distribution error.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for expired medical devices due to a distribution error, which fits the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported injuries.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 40 units of the Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001. The affected product is an integrated smoke evacuation pencil designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery.
The recall was initiated due to a distribution error that resulted in the affected lot being shipped expired. The specific lot number is 16240231, and the Global Trade Item Number (GTIN) is 07613327297799. The product was distributed internationally to the country of Canada.
Healthcare providers and facilities that have received this product should stop using it immediately and contact Stryker for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosu
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 40
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)
- Lot 16240231
- GTIN 07613327297799
Distribution
Distribution scope not specified by the agency.
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