Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
- Company
- Portex Inc
- Recall Initiated
- June 18, 2003
- Posted
- July 23, 2003
- Terminated
- March 31, 2004
- Recall Number
- Z-1039-03
- Quantity
- 11 units
- Firm Location
- Keene, NH
Reason for Recall
Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
Distribution
CA, GA, KA, MO
Lot / Code Info
Lot Number: 905486 EXP: 2004-05
Root Cause
Other
Action Taken
Portex notified four user facilities by telephone on June 18th and 19th, 2003 . The consignees were instructed to check their inventory for any affected product and to call to make arrangements for the return and credit of the affected product. If the product was in use, they were instructed to remove the fenestrated label on the inflation line and to inform the patient and healthcare provider of the discrepancy.