Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- August 7, 2019
- Terminated
- June 24, 2020
- Recall Number
- Z-2435-2019
- Quantity
- 237 units
- Firm Location
- Plainsboro, NJ
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
US Nationwide distribution.
Lot / Code Info
Lot #AA1901
Root Cause
Nonconforming Material/Component
Action Taken
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.