| Class 2 Device Recall Surgical Tubing | |
Date Initiated by Firm | April 21, 2008 |
Date Posted | September 05, 2008 |
Recall Status1 |
Terminated 3 on July 29, 2010 |
Recall Number | Z-1792-2008 |
Recall Event ID |
47873 |
Product Classification |
Tubing, fluid delivery - Product Code FPK
|
Product | Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038. |
Code Information |
Lot #: HI4900, HI4904, HI5906, HI5908, HI5912, HI5916, HI5920, HI5922, HI5924, HI5928, HI5930, HI5932, HI5934, HI5938, HI5940, HI5942, HI5944, HI5952, HI5956, HI5958, HI5974, HI5976, HI5984, HI6986, HI6988, HI6990, HI6994, HI6996, HI6998, HI6102, HI6108, HI6110, HI6114, HI6116, HI6122, HI6126, HI6130, HI6138, HI6144, HI6148, HI6154, HI6158, HI6164, HI7176, HI7178, HI7180, HI7182, HI7188, HI7202, HI7212, HI7204, HI7222, HI7226, HI7230, HI7240, HI7248, HI7254, HI7270, HI7272, HI7280, HI8292, HI8296, HI8304 and HI8316. |
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 | 6,895 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 |
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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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