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U.S. Department of Health and Human Services

Class 2 Device Recall DUET TRS Loading Units

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 Class 2 Recall
DUET TRS Loading Units
see related information
Date Posted March 19, 2012
Recall Status1 Open
Recall Number Z-1227-2012
Recall Event ID 61243
Premarket Notification
510(K) Number
K080898 
Product Classification Staple, Implantable - Product Code GDW
Product Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas
Code Information Lot Number: N1H0037LX
Recalling Firm/
Manufacturer
Covidien LP
60 Middletown Ave
North Haven, Connecticut 06473-3908
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact SAME
203-492-8165
Manufacturer Reason
for Recall
Missing component results in the stapler not firing.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at SDFeedback@Covidien.com or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax to (203) 822-6009 (all affected units must be returned with completed form through the Distributor). If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance at 203-492-5232, or Customer Service at 800-722-877 option 1 customer service.
Quantity in Commerce 1158 units
Distribution Worldwide distribution: USA (nationwide) and country of: Venezuela.
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 = GDW and Original Applicant = TYCO HEALTHCARE GROUP, LP
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