Medical device recalls Moderate risk

SunTech Medical Disposable recalled over labeling errors

Recall date
June 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Suntech Medical, Inc. recalls SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Recall number
Z-2277-2019
FDA classification
Class II
Brand / firm
Suntech Medical, Inc.
Sold / distributed
Pakistan

Why it was recalled

Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

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

What was recalled

SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

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