Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
FDA Recall Z-2435-2019 · Posted None
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeDXC
Date Initiated2019-08-07
Date Terminated2020-06-24
Product Quantity237 units
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
Firm Action
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: [email protected]
Outside USA: 781-565-1401.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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