Z-3085-2011

Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The ReNew Forceps...

Name: Z-3085-2011 Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The ReNew Forceps...
Creator: Microline Surgical, Inc.
Published: 2011-07-18
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2011-07-18 / Terminated / root cause: packaging

FDA source

Microline Surgical, Inc. began a recall of Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and... on 2011-07-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3085-2011
Status: Terminated
Initiated: 2011-07-18
Posted: 2011-08-29
Terminated: 2011-09-09
Recalling firm: Microline Surgical, Inc
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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
Root cause tag: packaging
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Lot Number: 00105332 Expiration date: 5-2016

Product code GEI

K981389Class IIDisposable Re-New ForcepsMicroline Pentax, Inc. / cleared 1998-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)