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Terminated

Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090

FDA Recall Z-0100-2008 · Posted 2007-11-07

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2007-09-18
Date Terminated2012-05-08
Product Quantity40 units

Reason for Recall

Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

Firm Action

Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.

Root Cause

Process control

Distribution Pattern

Nationwide.

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.

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