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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Tubing

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  Class 2 Device Recall Surgical Tubing see related information
Date Initiated by Firm April 21, 2008
Date Posted September 05, 2008
Recall Status1 Terminated 3 on July 29, 2010
Recall Number Z-1791-2008
Recall Event ID 47873
Product Classification Tubing, fluid delivery - Product Code FPK
Product Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.
Code Information Lot # AF4900, AF4904, AF5906, AF5908, AF5912, AF5916, AF5920, AF5922, AF5924, AF5928, AF5932, AF5934, AF5938, AF5942, AF5944, AF5950, AF5952, AF5956, AF5958, AF5970, AF5974, AF5976, AF5984, AF6986, AF6988, AF6990, AF6994, AF6996, AF6998, AF6102, AF6108, AF6110, AF6114, AF6116, AF6122, AF6126, AF6130, AF6134, AF6140, AF6148, AF6152, AF6158, AF6164, AF6170, AF7176, AF7182, AF7190, AF7196, AF7198, AF7200, AF7206, AF7210, AF7216, AF7218, AF7222, AF7226, AF7230, AF7234, AF7238, AF7240, AF7246, AF7250, AF7258, AF7264, AF7270, AF7272, AF7278, AF7286, AF8288, AF8292, AF8298, AF8300, AF8308 and AF8310.
Recalling Firm/
Manufacturer		 Mentor Texas, Inc
3041 Skyway Cir N
Irving TX 75038-3500
For Additional Information Contact
972-252-6060
Manufacturer Reason
for Recall		 During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
FDA Determined
Cause 2		 Other
Action A Customer Letter was issued to all consignees by the firm on 4/21/2008. Consignees were informed that a recent testing of these products discovered a potential defect in the packaging configuration, which could result in a loss of package integrity. Consignees were asked to review inventory and dispose of product and contact firm for credit.
Quantity in Commerce 12,557 boxes.
Distribution Class II Recall - Worldwide Distribution ---- including USA, Puerto Rico and countries of Argentina, Austria, Bermuda, Brazil, Canada, China, Costa Rica, Cyprus, Denmark, England, Germany, Greece, Guatemala, India, Italy, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Panama, Paraguay, Portugal, Slovak Republic, Slovenia, Spain, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
Total Product Life Cycle TPLC 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.
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