Integra Jarit GEMINI CLAMP Recalled Due to Potential Instrument Breakage
Integra LifeSciences Corp. is recalling 237 units of the Jarit GEMINI CLAMP because a small crack may cause corrosion and breakage after repeated sterilization.
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: The recall involves a medical device with a structural defect that could lead to breakage during a procedure. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 237 units of the Integra Jarit GEMINI CLAMP 9 1/4 inch (Cat. #140-332, Lot #AA1901). This medical device is used in vascular and cardiothoracic procedures for clamping and occluding vessels. The recall covers units distributed nationwide in the United States.
The recall was initiated because a small crack at the box lock corner may develop after multiple cleaning and sterilization cycles. This crack can increase the risk of corrosion, which weakens the instrument and may result in the need for premature replacement or breakage of the instrument during use.
Healthcare facilities and consumers who have this specific product should stop using it immediately. Users should contact the recalling firm for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 237
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 (1)
- Lot #AA1901
Distribution
Distributed nationwide across the United States.
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