Z-2435-2019 Class II Terminated
FDA device recall Z-2435-2019 was initiated by Integra LifeSciences Corp. on August 7, 2019 and is designated Class II. 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 replaceme… The recall status is terminated (terminated June 24, 2020). Affected quantity: 237 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- August 7, 2019
- Termination Date
- June 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 units
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
Distribution Pattern
US Nationwide distribution.
Code Information
Lot #AA1901