Recall Z-2660-2014— Bio-Detek, Inc.
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 with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.. 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 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 Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Reason for recall
Sterility of device is not assured
Data sourced from openFDA. This site is unofficial and independent of the FDA.