FDA recall Z-2087-2023

DeRoyal Industries Inc · Class II · device

Product

Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014

Reason for recall

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-05-30
Report date
2023-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2023