Z-2926-2018 Class II Terminated
FDA device recall Z-2926-2018 was initiated by Stanbio Laboratory, LP on February 8, 2018 and is designated Class II. 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. The recall status is terminated (terminated September 4, 2020). Affected quantity: 2,804 devices.
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