FDA-Device2021-04-14Class II
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Sharp Medical Products
Hazard
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Sold states
U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
Affected count
129 units (63 units for Human-use and 66 units for Non-Human use)
Manufactured in
14362 N Frank Lloyd Wright Blvd, N/A, Scottsdale, AZ, United States
Products
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2021Don't want to check this manually?
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