Medical device recalls

Cardiocommand Inc. recalls TAPSYSTEM Model 2A, REF 8002A

Recall date
June 24, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1976-2019
FDA classification
Class III
Brand / firm
Cardiocommand Inc.
Sold / distributed
United States - AR, NM, PA, TX, and WA.

Why it was recalled

There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

TAPSYSTEM Model 2A, REF 8002A

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