Medical device recalls Moderate risk

Linet Spol. S.r.o. recalls AVE 2 Birthing Bed

Recall date
January 7, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0991-2019
FDA classification
Class II
Brand / firm
Linet Spol. S.r.o.
Sold / distributed
AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX

Why it was recalled

LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.

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

What was recalled

AVE 2 Birthing Bed

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