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U.S. Department of Health and Human Services

Class 2 Device Recall Taut Intraducers

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 Class 2 Device Recall Taut Intraducerssee related information
Date Initiated by FirmOctober 14, 2015
Create DateNovember 16, 2015
Recall Status1 Terminated 3 on December 11, 2017
Recall NumberZ-0277-2016
Recall Event ID 72418
510(K)NumberK992907 
Product Classification Catheter, peritoneal - Product Code GBW
ProductTaut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Code Information Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information ContactMelissa Lewis
610-378-0131
Manufacturer Reason
for Recall		The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionRecall letters were sent to customers and distributors. The letter requested that the accounts discontinue use and quarantine for return any product. The distributors were requested to conduct a sub-recall. The letters included a Recall Acknowledgement Form which was to be returned to Teleflex.
Quantity in Commerce2050 ea.
DistributionNationwide Distribution including the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GBW
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