The Recall Desk

FDA (Devices) recall action 76008

Bard Access Systems recalled 2 products on 2017-01-18

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2017-01-18
Critical
0
Units
15,200

Why these products were recalled

Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

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

1–2 of 2

  • ModerateFDA (Devices)··2017-01-18

    Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors

    Bard Access Systems is recalling MiniLoc Safety Infusion Sets because some units have needle lengths and gauges that differ from the label descriptions.

    Product
    MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood…
    Category
    Distribution
    12 states
  • ModerateFDA (Devices)··2017-01-18

    Bard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors

    Bard Access Systems is recalling SafeStep Huber Needle Sets because some units may have needle lengths or gauges that differ from the label.

    Product
    SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through…
    Category
    Distribution
    12 states