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DeRoyal SHOULDER PACK, REF 89-6830.13

FDA Recall #Z-0579-2023 — Class II — November 3, 2022

Recall #Z-0579-2023 Date: November 3, 2022 Classification: Class II Status: Ongoing

Product Description

DeRoyal SHOULDER PACK, REF 89-6830.13

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

876 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 56184005 exp 11/1/2023; Lot 56254392 exp 10/1/2023; Lot 56777927 exp 1/1/2024; Lot 57391031 exp 2/1/2024; Lot 57684204 exp 5/1/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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