Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot Numbers: K518075, K520177, K548751, K573622, K614995
Products Sold
Lot Numbers: K518075, K520177, K548751, K573622, K614995
Smiths Medical ASD, Inc. is recalling Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070 due to Guiding catheter may have thinner and weaker sidewalls than designed, and may break.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
Recommended Action
Per FDA guidance
Smith Medical ASD initiated recall by letter on/about about May 16, 2005.
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