FDASeptember 18, 2019device

BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is a...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

angiodynamics inc navilyst medical incangiodynamicsangiodynamics inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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