Recall Z-3085-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical, Inc.
Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula
| Date | Aug 29, 2011 (initiated Jul 18, 2011) |
| Status | Terminated |
| Reason | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper |
| Root cause | Packaging process control |
| Action | Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked |
| Quantity | 170 units |
| Distribution | Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981389 | DISPOSABLE RE-NEW FORCEPS Microline Pentax, Inc., May 29, 1998 |