Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1790-2008 · Posted 2008-09-05

Recalling FirmMentor Texas, Inc
Recall StatusTerminated
Product CodeFPK
Date Initiated2008-04-21
Date Terminated2010-07-29
Product Quantity18,684 boxes.

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑