Medical device recalls Moderate risk

Stryker Instruments Div. of Stryker Corporation recalls T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment

Recall date
February 23, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1508-2018
FDA classification
Class II
Brand / firm
Stryker Instruments Div. of Stryker Corporation
Sold / distributed
US Nationwide and Ireland, Japan, South Korea, UK

Why it was recalled

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

What was recalled

T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment

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