Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
This recall has been terminated (originally issued November 7, 2007).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- September 18, 2007
- Posted
- November 7, 2007
- Terminated
- May 8, 2012
- Recall Number
- Z-0100-2008
- Quantity
- 40 units
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
Lot / Code Info
Lot Number: 1155185
Root Cause
Process control
Action Taken
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.
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