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 Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080

FDA Recall Z-0868-05 · Posted 2005-06-04

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2005-05-16
Date Terminated2012-05-08

Reason for Recall

Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

Firm Action

Smith Medical ASD initiated recall by letter on/about about May 16, 2005.

Root Cause

Other

Distribution Pattern

Natiowide Foreign: Canada, Mexico and East Timor.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITPortex, Inc. · 2003-07-18

Official Source

View FDA Recall →

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

↑