FDA Device recall Z-0052-2015
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection wit…
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection wit… by Bio Detek, citing product sterility is not assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0052-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-16 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bio Detek |
| Distribution | US |
Product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 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
Identifiers
| code_info | Lot Numbers: 1614, 1814, 1914 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.