medical Class II Updated 2018-10-17

Angiodynamics Inc. (Navilyst Medical Inc.) recalls BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BI

Recalled Product

BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - 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

BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 5363172
View official government recall

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