PlainRecalls
FDA Devices Moderate Class II Terminated

Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332

Reported: September 11, 2019 Initiated: August 7, 2019 #Z-2435-2019

Product Description

Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332

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

Details

Units Affected
237 units
Distribution
US Nationwide distribution.
Location
Plainsboro, NJ

Frequently Asked Questions

What product 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. Recalled by Integra LifeSciences Corp.. Units affected: 237 units.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2435-2019.