Recall Z-2435-2019
Integra LifeSciences Corp. · initiated August 7, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Codes / lots: Lot #AA1901
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
FDA-determined 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.
Details
- Recall number
- Z-2435-2019
- Initiated
- August 7, 2019
- Terminated
- June 24, 2020
- Product code
- DXC – Clamp, Vascular
- Quantity
- 237 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ