Recall Z-2926-2018— Stanbio Laboratory, LP

Name: FDA recall Z-2926-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-08

Class II · Terminated

Class II FDA medical device recall by Stanbio Laboratory, LP, initiated 2018-02-08, terminated 2020-09-04. It names one FDA 510(k) clearance: K081719. 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: The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts..

Recalling firm: Stanbio Laboratory, LP
Classification: Class II
Status: Terminated
Initiated: 2018-02-08
Terminated: 2020-09-04
Firm location: Boerne, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMStanbio Laboratory·cleared 2008-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.