Smiths Medical ASD, Inc. Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot Number: 1155185
Products Sold
Lot Number: 1155185
Smiths Medical ASD, Inc. is recalling Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090 due to Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026