Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.

FDA device recall Z-1790-2008 · posted 2008-09-05 · Terminated

Recall details

Recalling firm

Mentor Texas, Inc

Reason for recall

During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.

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.

Root cause

Other

Status

Terminated

Product code

FPK

Quantity affected

18,684 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, Gua

Date initiated

2008-04-21

Date posted

2008-09-05

Date terminated

2010-07-29

Location

Irving, TX