FDA-Device2019-04-03Class II
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
COVIDIEN LLC
Hazard
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Sold states
The products were distributed to the following US states: CA, NJ, and WA.
Affected count
25 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2019Don't want to check this manually?
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