Recall Z-2435-2019— Integra LifeSciences Corp.

Name: FDA recall Z-2435-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-07

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2019-08-07, terminated 2020-06-24. It names one FDA 510(k) clearance: K102048. Product: Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332. Reason: 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.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2019-08-07
Terminated: 2020-06-24
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102048 — ATRAUMATIC VASCULAR CLAMPSGeomed Medizin-Technik GmbH & Co. KG·cleared 2010-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.