United StatesDiversatek Healthcare Viper 3-Stage balloon dilators (Fixed Wire REF 1204-08 and Wire Guided REF 1205-15, REF 1205-18, REF 1205-20) in the sizes shown, identified by the listed UDI/DI numbers (00816734021699, 00816734021781, 00816734021798, 00816734021804) and the lot numbers provided, were distributed in multiple US states, Brazil and Belgium. They were recalled because the catheter inflation tag may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
What's being recalled
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Recalling firm: Diversatek Healthcare, Milwaukee, WI, United States.
How to identify it
UDI/DI 00816734021699, Lot Numbers: 005983 UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629 UDI/DI 00816734021798, Lot Numbers: 005985 UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574
The hazard
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)