Z-2926-2018 Class II Terminated

Recalled by Stanbio Laboratory, LP — Boerne, TX

Recall Details

Product Type
Devices
Report Date
September 5, 2018
Initiation Date
February 8, 2018
Termination Date
September 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,804 devices

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.

Distribution Pattern

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.

Code Information

Serial number range of affected power adapters: 41800001-41804000