Diversatek Viper balloon dilator tags may show incorrect inflation parameters
Diversatek Viper 3-Stage Wire Guided Balloon Dilators are being recalled because the catheter inflation tag may show an incorrect part number with wrong balloon diameters and pressures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where incorrect labelled inflation parameters could lead to the wrong diameter or pressure being used, a risk of harm with no injuries reported.
Plain-English summary
The Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15 mm-16.5 mm-18 mm, REF 1205-18, UDI/DI 00816734021798, lot 005985, is being recalled. The action covers 250 units.
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. The tag is what the operator uses to set inflation for each stage of dilation. The FDA classified the action as Class II.
Distribution was within the United States across a large number of states, and internationally including Brazil and Belgium. The dilators are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF number, UDI/DI and lot number above, quarantine it, and follow the instructions issued by Diversatek.
The recalled product
- Product
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Manufacturer
- Diversatek Healthcare
- Category
- Medical Device — Balloon dilator
- Hazard
- mislabeling
- incorrect-parameters
- balloon-dilation
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00816734021798
- Lot Numbers: 005985
Distribution
Distributed in 19 states:
- AL
- AZ
- CA
- FL
- IA
- IL
- KS
- LA
- MI
- MO
- MS
- NC
- NJ
- NY
- OH
- PA
- RI
- TX
- VA
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