Medical device recalls Moderate risk

Stanbio Laboratory, LP recalls Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H…

Recall date
February 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2926-2018
FDA classification
Class II
Brand / firm
Stanbio Laboratory, LP
Sold / distributed
Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.

Why it was recalled

The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

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

What was recalled

Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

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