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U.S. Department of Health and Human Services

Class 2 Device Recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips

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  Class 2 Device Recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips see related information
Date Initiated by Firm May 12, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on August 13, 2015
Recall Number Z-1986-2014
Recall Event ID 68495
510(K)Number K981389  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips
Ref 3221
Code Information Lot Numbers: 00115342
Recalling Firm/
Manufacturer		 Microline Surgical, Inc.
800 Cummings Ctr Ste 166t
Beverly MA 01915-6171
For Additional Information Contact
978-922-9810
Manufacturer Reason
for Recall		 Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.
Quantity in Commerce 150 units
Distribution Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
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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