—#175161

Product

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

FDA product code: DXC — Clamp, Vascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K102048
Affected lot / code info: Lot #AA1901

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Integra LifeSciences notified consignees (Hospitals, Distributors) by letter delivered via FedEx on August 7, 2019. Letter states reason for recall, health risk and action to take: 1. Review your inventory and determine if you have any impacted lots listed above.2. If you do have product with an affected Lot Number, stop using the product immediately and remove the product from service. 3. Complete the attached form. If you do not have affected product, check the box, I do not have any product with the lot number. 4. If you do have affected product, check the box I do have product(s) with the lot number. Record the total quantity of affected product you have.5. Complete the other information and Return the completed Acknowledgement and Return Form by email or fax indicating your receipt and review of this notification. Keep a copy of the form for your records. Questions contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-08-07
Terminated: 2020-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175161. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.