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DeRoyal BASIC EYE PACK, REF 89-8337.09

FDA Recall #Z-0607-2023 — Class II — November 3, 2022

Recall #Z-0607-2023 Date: November 3, 2022 Classification: Class II Status: Ongoing

Product Description

DeRoyal BASIC EYE PACK, REF 89-8337.09

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

50 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 57118632 exp 9/1/2024; Lot 57184285 exp 12/1/2024; Lot 57630628 exp 4/1/2025; Lot 57745978 exp 4/1/2025: Lot 57688413 exp 12/01/2024

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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