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U.S. Department of Health and Human Services

Class 2 Device Recall Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip

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  Class 2 Device Recall Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip see related information
Date Initiated by Firm July 18, 2011
Date Posted August 29, 2011
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-3085-2011
Recall Event ID 59469
510(K)Number K981389  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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
Code Information Lot Number: 00105332 Expiration date: 5-2016
Recalling Firm/
Manufacturer		 Microline Surgical, Inc.
800 Cummings Ctr Ste 166t
Beverly MA 01915-6171
For Additional Information Contact
978-922-9819
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MICROLINE PENTAX, INC.
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