FDA-Device2023-11-22Class II
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
ROi CPS LLC
Hazard
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Sold states
MO
Affected count
134 units
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0315-2024Don't want to check this manually?
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