Reported Feb 5, 2020 · Terminated
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows
ROi CPS 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: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows
9 of 9 products
| Model / number | Product as published |
|---|---|
830015012 | regard LD00200L-VAG DELIVERY MOTHER - JOPLIN |
830027 | regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter |
830026 | regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter |
830024 | regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter |
| — | regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 |
830028 | regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter |
830084 | regard LD00866B-VAG DELIVERY MOTHER - LEBANON |
830014 | regard LD00199NL-C SECTION MOTHER - JOPLIN |
830034 | regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure. |
- Amount recalled
- 412 packs
Where it was sold
Why it was recalled
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
This product could cause temporary or reversible health problems — stop using it.
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