PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 5, 2018 Initiated: February 8, 2018 #Z-2926-2018

Product Description

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.

Details

Recalling Firm
Stanbio Laboratory, LP
Units Affected
2,804 devices
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.
Location
Boerne, TX

Frequently Asked Questions

What product 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.. Recalled by Stanbio Laboratory, LP. Units affected: 2,804 devices.
Why was this product recalled?
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2926-2018.