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U.S. Department of Health and Human Services

Class 2 Device Recall Microline Renew Fenestrated Control Tip Grasper

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 Class 2 Recall
Microline Renew Fenestrated Control Tip Grasper
see related information
Date Posted May 20, 2014
Recall Status1 Open
Recall Number Z-1635-2014
Recall Event ID 68012
Premarket Notification
510(K) Number
K981389 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Code Information Lot Numbers: 00116169 and 00115866
Recalling Firm/
Manufacturer
Microline Surgical
50 Dunham Rd
Beverly, Massachusetts 01915-1882
Manufacturer Reason
for Recall
Grasper jaw may break when force is applied to the jaw
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Microline Surgical sent an Recall Notice dated April 14, 2014, via overnight mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please contact Microline Customer Service ( 978) 922-9810 for a RGA number to return all unused product. This recall should be carried out to the hospital level. Please complete and return the enclosed response form as soon as possible.
Quantity in Commerce 540 units
Distribution Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MICROLINE PENTAX, INC.
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