Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
FDA Recall #Z-2089-2023 — Class II — May 30, 2023
Product Description
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
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
3 packs
Distribution
US Nationwide distribution.
Code Information
a) REF 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated