The Recall Desk

FDA (Devices) recall action 69842

Smiths Medical ASD, Inc. recalled 3 products on 2015-01-07

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
2015-01-07
Critical
0
Units
391,200

Why these products were recalled

Needle is not captured in the needle safety sheath in specific lots.

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

1–3 of 3

  • HighFDA (Devices)··2015-01-07

    Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

    Smiths Medical ASD, Inc. is recalling 10,000 units of Needle Pro Edge Safety Hypodermic Needles because the needle may not be captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Distribution
    27 states
  • HighFDA (Devices)··2015-01-07

    Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

    Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge safety hypodermic needles because the needle is not captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Distribution
    27 states
  • HighFDA (Devices)··2015-01-07

    Smiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles

    Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge Safety Devices because the needle is not captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Distribution
    27 states