FDA-Device2023-07-12Class II
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
DeRoyal Industries Inc
Hazard
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Sold states
US Nationwide distribution.
Affected count
40 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2023Don't want to check this manually?
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