Medical device recalls Moderate risk

Johnson & Johnson Surgical Vision Inc recalls TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

Recall date
April 6, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1033-2022
FDA classification
Class II
Brand / firm
Johnson & Johnson Surgical Vision Inc
Sold / distributed
Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.

Why it was recalled

Potential breach in the sterility barrier for tray ring covers.

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

What was recalled

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

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