Date Initiated by Firm |
April 14, 2014 |
Date Posted |
May 20, 2014 |
Recall Status1 |
Terminated 3 on September 02, 2015 |
Recall Number |
Z-1635-2014 |
Recall Event ID |
68012 |
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 MA 01915-1882
|
Manufacturer Reason for Recall |
Grasper jaw may break when force is applied to the jaw
|
FDA Determined Cause 2 |
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
|
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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.
|
510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = MICROLINE PENTAX, INC.
|