Smiths Medical ASD, Inc. PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot Number: K223373
Products Sold
Lot Number: K223373
Smiths Medical ASD, Inc. is recalling PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080 due to Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
Recommended Action
Per FDA guidance
Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
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 noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI
Page updated: Jan 10, 2026