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.
FDA Recall Z-2926-2018 · Posted None
Advertisement
Recalling FirmStanbio Laboratory, LP
Recall StatusTerminated
Product CodeGKR
Date Initiated2018-02-08
Date Terminated2020-09-04
Product Quantity2,804 devices
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.
Firm Action
The recall was initiated via letter dated 2/7/2018 by first class mail letter on 2/8/2018 instructing the consignee to stop using the adapter if it is affected and it will be replaced.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement