FDA-Device2020-06-17Class II

Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

ROi CPS LLC
Hazard

Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.

Sold states
US nationwide distribution in the states of MO, AR and OK.
Affected count
40 Kits.
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2020

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