Diversatek Healthcare: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

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.

Details from the source

Reason for recall: 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. Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium Quantity: 1383 units Lot/code info: UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574

UPC codes

00816734021804

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.