Recall Z-1635-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
| Date | May 20, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| Reason | Grasper jaw may break when force is applied to the jaw |
| Root cause | Nonconforming Material/Component |
| Action | Microline Surgical sent an Recall Notice dated April 14, 2014, via overnight mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please contact Microline Customer Service ( 978) 922-9810 f |
| Quantity | 540 units |
| Distribution | Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981389 | DISPOSABLE RE-NEW FORCEPS Microline Pentax, Inc., May 29, 1998 |