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 Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080

FDA Recall Z-1017-04 · Posted 2004-07-20

Recalling FirmSmiths Medical ASD, Inc
Recall StatusTerminated
Product CodeJOH
Date Initiated2004-05-19
Date Terminated2006-05-02
Product Quantity60,400

Reason for Recall

Incompatible products may cause potential trachea trauma

Firm Action

Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902180TRACHEAL TUBE STYLETSims Surgical, Inc. · 1990-07-19

Official Source

View FDA Recall →

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

↑