Stryker Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
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: This is a Class II medical device with an expiration date labeling error that creates risk of use beyond the validated 36-month shelf life, potentially compromising sterility and performance. No illnesses or injuries have been reported, placing this in the 'risk-of-harm without reported injury' category.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-200-015) due to an expiration date labeling error. The product label incorrectly indicates a shelf life of 54 months (4.5 years), while the correct shelf life is 36 months (3 years).
These surgical instruments have been distributed throughout the United States and internationally to Australia, Canada, Japan, Korea, and Singapore. The affected lot numbers are: 200525012, 200716010, 200731013, and 200806013.
The labeling error could result in these products being retained and used beyond their validated 36-month shelf life, which may compromise product sterility and performance.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
- Manufacturer
- Stryker Corporation
- Hazard
- shelf-life-mislabeling
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 (5)
- GTIN: 7613327300314
- Lot Numbers: 200525012
- 200716010
- 200731013
- 200806013
Distribution
Distributed nationwide across the United States.
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