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

Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm Reference Number: 100/111/035

FDA Recall Z-0993-03 · Posted 2003-07-19

Recalling FirmPortex Ltd.
Recall StatusTerminated
Date Initiated2003-05-16
Date Terminated2006-05-02
Product Quantity270 units

Reason for Recall

Tracheal tubes may be non-sterile

Firm Action

Portex Inc. Keene,NH initiated the recall by telephone to direct accounts on 5/16/03. A follow-up Recall Notification letter was issued by Federal Express on May 17, 2003. Dealers were asked to provide a consignee list or contact their accounts directly. Unused product is requested to be returned from the distributors and medical facilities.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

↑