—#64375

Product

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

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K031057
Affected lot / code info: Lot Number: 1155185

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-09-18
Posted by FDA: 2007-11-07
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64375. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.