Medical device recalls Moderate risk

Dutch Ophthalmic USA, Inc. recalls Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

Recall date
April 14, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2097-2021
FDA classification
Class II
Brand / firm
Dutch Ophthalmic USA, Inc.
Sold / distributed
Nationwide Distribution in the states of CA, FL, MA, and UT.

Why it was recalled

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

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