Diversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error
Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators because the catheter inflation tag may contain incorrect part numbers and balloon diameter and pressure specifications.
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: This is an FDA Class II recall of a medical device where incorrect labeling of critical operational parameters (balloon diameters and inflation pressures) presents a risk of harm if clinicians use incorrect specifications during balloon dilation procedures. No illnesses or injuries are reported, but the potential for patient harm from using wrong pressures or diameters is significant.
Plain-English summary
Diversatek Healthcare is recalling the Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm (REF 1204-08) due to an error in the catheter inflation tag attached to the device. The tag may contain an incorrect part number, along with incorrect balloon diameter sizes and inflation pressures for each stage.
15 units of this product have been distributed across multiple U.S. states (MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL) and internationally to Brazil and Belgium. The affected lot is 005983, identified by UDI/DI 00816734021699.
Clinicians and users who have this device should verify the correct specifications against official product documentation and contact Diversatek Healthcare with any questions about proper use or device specifications.
The recalled product
- Product
- Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
- Manufacturer
- Diversatek Healthcare
- Hazard
- labeling-error
- incorrect-specifications
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 00816734021699
- Lot Numbers: 005983
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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