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Class 2 Device Recall Taut Intraducers |
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Date Initiated by Firm |
October 14, 2015 |
Create Date |
November 16, 2015 |
Recall Status1 |
Terminated 3 on December 11, 2017 |
Recall Number |
Z-0277-2016 |
Recall Event ID |
72418 |
510(K)Number |
K992907
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Product Classification |
Catheter, peritoneal - Product Code GBW
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Product |
Taut 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
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For Additional Information Contact |
Melissa Lewis 610-378-0131
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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.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Recall 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 Commerce |
2050 ea. |
Distribution |
Nationwide 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 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 = GBW and Original Applicant = TAUT, INC.
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