Recall Z-0053-2015— Bio-Detek, Inc.
Class II · Terminated
Class II FDA medical device recall by Bio-Detek, Inc., initiated 2014-09-16, terminated 2016-05-03. It names one FDA 510(k) clearance: K943698. Product: ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 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.. Reason: Product sterility is not assured.
- Recalling firm
- Bio-Detek, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-16
- Terminated
- 2016-05-03
- Firm location
- Pawtucket, RI, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 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.
Reason for recall
Product sterility is not assured
Data sourced from openFDA. This site is unofficial and independent of the FDA.