FDA-Device2019-11-27Class II
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Sold states
Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
Affected count
582
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2020Don't want to check this manually?
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