The Recall Desk

FDA (Devices) recall action 75322

Angiodynamics Inc. (Navilyst Medical Inc.) recalled 3 products on 2016-12-14

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-12-14
Critical
0
Units
—

Why these products were recalled

Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Angiodynamics is recalling BioFlo PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy,
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2016-12-14

    Navilyst Recalls Xcela PICC Kits Due to Incorrect Glove Expiration Dates

    Navilyst Medical is recalling Xcela Power Injectable PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Navilyst is recalling BioFlo PICC Maximal Barrier Nursing Kits because the included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN #
    Category
    Distribution
    20 states