DeRoyal NEURO PACK, REF 89-10171.06

FDA Recall #Z-0675-2023 — Class II — November 3, 2022

Recall #Z-0675-2023 Date: November 3, 2022 Classification: Class II Status: Ongoing

Product Description

DeRoyal NEURO PACK, REF 89-10171.06

Reason for Recall

XXX

Recalling Firm

DeRoyal Industries Inc — Powell, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

159 kits

Distribution

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Code Information

Lot Numbers: Lot 57184744 exp 5/1/2026; Lot 57685899 exp 3/1/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated