FDA-Device2020-06-24Class II
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.
Resource Optimization & Innovation LLC
Hazard
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Sold states
US Nationwide distribution including in the states of MO, NC.
Affected count
9,360 units
Manufactured in
645 Maryville Centre Dr Ste 200, Saint Louis, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2368-2020Don't want to check this manually?
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