Mentor Texas, Inc Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
Brand
Mentor Texas, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Mentor Texas, Inc is recalling Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038. due to During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026