CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report
Integra Jarit Gemini Clamp 9 - used in vascular recalled
Integra LifeSciences is recalling Integra Jarit Gemini Clamp 9 - used in vascular and cardiothoracic procedures used for, distributed nationwide in the US. The recall was initiated on 7 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2435-2019
- FDA event ID
- 83418
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2019
- FDA classified
- 30 Aug 2019
- Reported
- 11 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Aug 2019 | Recall initiated by company | |
| 30 Aug 2019 | Classified by FDA | +23 days |
| 11 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Integra Jarit Gemini Clamp 9 - used in vascular and cardiothoracic procedures used for recalled?
Yes. Integra LifeSciences recalled Integra Jarit Gemini Clamp 9 - used in vascular and cardiothoracic procedures used for on 7 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-2435-2019.
Why was it 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
Which lots are affected?
Lot #AA1901
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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