Class II
Medical Device Recall: BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
Angiodynamics, Inc. · March 18, 2024
Reason for Recall
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Distribution
VA
States Affected
VA
Quantity Affected
250 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1774-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.