FDA-Device2022-05-18Class II
Regard brand CABG Pack A and B - Spartanburg
ROi CPS LLC
Hazard
Kits were packed into shipping boxes incorrectly.
Sold states
Recall impacted one domestic consignee in NC
Affected count
85 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Regard brand CABG Pack A and B - Spartanburg
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2022Don't want to check this manually?
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