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

PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080

FDA Recall Z-0569-04 · Posted 2004-07-20

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2003-12-12
Date Terminated2006-05-02
Product Quantity30 CASES (2/CASE)

Reason for Recall

Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm

Firm Action

Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.

Root Cause

Other

Distribution Pattern

AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980466PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULASims Portex, Inc. · 1998-02-24

Official Source

View FDA Recall →

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

↑