FDA Recall Terminated

Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip Ref: 3642 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

Recall: Z-3086-2011 · Initiated July 18, 2011

Recall

Recall Number: Z-3086-2011
Event Number: 59469
Firm: Microline Surgical, Inc.
FEI Number: 1000137656
Product Code: GEI
Status: Terminated
Root Cause: Packaging process control
Initiated: July 18, 2011
Posted: August 29, 2011
Terminated: September 9, 2011
Address: 800 Cummings Ctr, Ste 166t, Beverly, MA, 01915-6171

Description

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

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 to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.

Distribution

Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.

Quantity

300 units