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Terminated

Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013

FDA Recall Z-0572-04 · Posted 2004-07-20

Recalling FirmSmiths Medical ASD, Inc
Recall StatusTerminated
Product CodeBSR
Date Initiated2004-01-26
Date Terminated2012-05-08
Product Quantity46 cases (230 UNITS)

Reason for Recall

Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr

Firm Action

Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter.

Root Cause

Other

Distribution Pattern

CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA

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.

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