The Recall Desk

FDA (Devices) recall action 83907

Angiodynamics Inc. (Navilyst Medical Inc.) recalled 5 products on 2019-11-27

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-11-27
Critical
0
Units
2,910

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Filled Non-Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    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
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - 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 produc
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters

    Angiodynamics Inc. is recalling BIOFLO 8F catheters because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2019-11-27

    Angiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect

    Angiodynamics Inc. is recalling 582 XCELA implantable port kits because snap lock connectors may not meet specifications, preventing catheter insertion.

    Product
    XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - 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 product
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - 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
    Category
    Distribution
    23 states