Recall Z-2435-2019 ยท DXC Clamp, Vascular
Integra LifeSciences Corp.
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
| Date | Aug 7, 2019 |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 237 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102048 | ATRAUMATIC VASCULAR CLAMPS Geomed Medizin-Technik GmbH & Co. KG, Nov 9, 2010 |