FDA recall Z-2926-2018

Product

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.

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-02-08

Report date

2018-09-05

Termination date

2020-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boerne, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2926-2018