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U.S. Department of Health and Human Services

Class 2 Device Recall TAUT ADAPt

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 Class 2 Recall
TAUT ADAPt
see related information
Date Posted June 23, 2010
Recall Status1 Terminated on October 27, 2010
Recall Number Z-1890-2010
Recall Event ID 55676
Premarket Notification
510(K) Number
K082156 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Intended use: The ADAPt Balloon Open Access Port is indicated for the use in thoracic, abdominal and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. This a single use device, provided sterile.
Code Information Catalog Number: 41244, Serial/Lot number: 01E0900215
Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham, North Carolina 27703-9000
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Angela Brown
919-544-8000
Manufacturer Reason
for Recall
Balloon does not hold air or water once inflated.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Teleflex Medical, sent an "Urgent Medical Device Recall" letter dated May 10, 2010 to customers The letter described the product, problem and action to be taken by the customers. They were instructed to return all of the affected product to Teleflex. Each distributor was instructed to forward the letter to their customers to retrieve relevant product from those locations. A second mailing to non-responding customers will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, email, or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. Teleflex Medical will communicate to FDA on the status of recall activities. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 366 eaches
Distribution Worldwide distribution: USA including states of AR, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NY, OR, PA, WI, WV and country of France.
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 = GCJ and Original Applicant = TELEFLEX MEDICAL
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