Recall Z-1987-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical, Inc.
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
| Date | Jul 2, 2014 (initiated May 12, 2014) |
| Status | Terminated |
| Reason | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw |
| Root cause | Nonconforming Material/Component |
| Action | Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions. |
| Quantity | 6290 units |
| Distribution | Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981389 | DISPOSABLE RE-NEW FORCEPS Microline Pentax, Inc., May 29, 1998 |