medical Class II Updated 2019-11-27

Angiodynamics Inc. (Navilyst Medical Inc.) recalls BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140,

Recalled Product

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 also indicated for blood specimen withdrawal.


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: 5487932, 5487933, 5488008
View official government recall

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