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Class 2 Device Recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) |
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Date Initiated by Firm |
May 12, 2014 |
Date Posted |
July 02, 2014 |
Recall Status1 |
Terminated 3 on August 13, 2015 |
Recall Number |
Z-1987-2014 |
Recall Event ID |
68495 |
510(K)Number |
K981389
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product |
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222 |
Code Information |
Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278 |
Recalling Firm/ Manufacturer |
Microline Surgical, Inc. 800 Cummings Ctr Ste 166t Beverly MA 01915-6171
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For Additional Information Contact |
978-922-9810
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Manufacturer Reason for Recall |
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
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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 |
6290 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
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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.
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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = MICROLINE PENTAX, INC.
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