medical Class II Updated 2019-11-27

Angiodynamics Inc. (Navilyst Medical Inc.) recalls BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat

Recalled Product

BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 5478033, 5482424
View official government recall

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