Recall Z-1945-2019— Bio-Detek, Inc.

Name: FDA recall Z-1945-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-28

Class II · Terminated

Class II FDA medical device recall by Bio-Detek, Inc., initiated 2019-05-28, terminated 2020-06-01. It names one FDA 510(k) clearance: K960676. Product: ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single). Reason: Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy..

Recalling firm: Bio-Detek, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Terminated: 2020-06-01
Firm location: Pawtucket, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K960676 — ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004Zoll Medical Corp·cleared 1996-06-05

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

ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

Reason for recall

Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

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