Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
FDA Recall #Z-2087-2023 — Class II — May 30, 2023
Product Description
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.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
40 units
Distribution
US Nationwide distribution.
Code Information
a) REF '89-5014, GTIN 50749756217908 (cs), 00749756217903 (unit), , Lot Numbers: 58770294
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated