Integra LifeSciences Corp. recalls Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding…
- Recall date
- August 7, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2435-2019
- FDA classification
- Class II
- Brand / firm
- Integra LifeSciences Corp.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
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