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-1051-2022

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