FDA-Device2023-07-12Class II

Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

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
3 packs
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2089-2023

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