Reported Jun 24, 2020 · Terminated
Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used…
Resource Optimization & Innovation LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Resource Optimization & Innovation LLC · 645 Maryville Centre Dr Ste 200 · Saint Louis, MO · 63141-5846
Is this the product you have?
- Regard SRHS GIC Port A Cath, Sterile
- Qty 20/case - Product UsageThe Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices
- Lot codes and dates
- Item number 303394REGlot
- numbers
259427262441264440268589268915271008and 269694
- Amount recalled
- 9,360 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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