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

FDA device recall Z-3086-2011 · posted 2011-08-29 · Terminated

Recall details

Recalling firm

Microline Surgical, Inc.

Reason for recall

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 taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

GEI

Quantity affected

300 units

Distribution

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

Date initiated

2011-07-18

Date posted

2011-08-29

Date terminated

2011-09-09

Location

Beverly, MA

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