The Recall Desk

FDA (Devices) recall action 85632

Resource Optimization & Innovation LLC recalled 2 products on 2020-06-24

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
2020-06-24
Critical
0
Units
22,000

Why these products were recalled

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

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

  • HighFDA (Devices)··2020-06-24

    Resource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes

    Resource Optimization & Innovation LLC is recalling Regard SRHS GIC Port A Cath devices because holes in the packaging may compromise the sterile field.

    Product
    Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2020-06-24

    Resource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects

    Resource Optimization & Innovation LLC is recalling Regard SRHS Central Line Kits because holes in the packaging may compromise the sterile field.

    Product
    Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
    Category
    Distribution
    3 states