FDA-Device2021-11-10Class II
COVENA PICC Sleeve
Queen Comfort Products lLC
Hazard
Marketed without FDA clearance
Sold states
US Nationwide distribution.
Affected count
91 units
Manufactured in
8517 Chatsworth Ln, N/A, Waxhaw, NC, United States
Products
COVENA PICC Sleeve
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2022Don't want to check this manually?
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