Medical device recalls Moderate risk

Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

Recall date
September 1, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0086-2023
FDA classification
Class II
Brand / firm
Johnson & Johnson Surgical Vision, Inc.
Sold / distributed
Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwait…

Why it was recalled

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

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

What was recalled

Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

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