The Recall Desk

FDA (Devices) recall action 78483

Owen Mumford USA, Inc. recalled 2 products on 2018-01-24

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
2018-01-24
Critical
0
Units
—

Why these products were recalled

Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-01-24

    Owen Mumford Recalls Unifine Pentips Pen Needles Due to Sterility Concerns

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Consumers should check for discoloration on the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Distribution
    27 states
  • HighFDA (Devices)··2018-01-24

    Owen Mumford Recalls Unifine Pentips Due to Potential Sterility Compromise

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Distribution
    27 states