Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.
This recall has been terminated (originally issued September 5, 2008).
- Company
- Mentor Texas, Inc
- Recall Initiated
- April 21, 2008
- Posted
- September 5, 2008
- Terminated
- July 29, 2010
- Recall Number
- Z-1791-2008
- Quantity
- 12,557 boxes.
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.