Recall Z-2658-2014— Bio-Detek, Inc.

Name: FDA recall Z-2658-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-26

Class II · Terminated

Class II FDA medical device recall by Bio-Detek, Inc., initiated 2014-08-26, terminated 2016-05-03. It names one FDA 510(k) clearance: K943698. Product: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.. Reason: Sterility of device is not assured.

Recalling firm: Bio-Detek, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-26
Terminated: 2016-05-03
Firm location: Pawtucket, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K943698 — STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODESZoll Medical Corp·cleared 1994-12-28

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 Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

Reason for recall

Sterility of device is not assured

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