Recall Z-2206-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Integra LifeSciences Corp.
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected |
| Root cause | Under Investigation by firm |
| Action | Integra LifeSciences issued recall letter on July 19, 2019 advising of problem, health risk and action to take: 1.Review your inventory and determine if you have any impacted lot. 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 th |
| Quantity | 125 units |
| Distribution | KY,NJ, RI, TX, WA Foreign: BE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083895 | CODMAN ISOCOOL BIPOLAR FORCEPS Codman & Shurtleff, Inc., Jun 23, 2009 |