Bio-Detek, Inc. Recall: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (
Bio-Detek, Inc. Recall: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft ( is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Bio-Detek, Inc.; Product: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Prod
| Recalling firm | Bio-Detek, Inc. |
|---|---|
| Product | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany. |
| Recall initiated | 20140916 |
| Recall number | Z-0055-2015 |
| Category | device |
| State | RI |
| Country | United States |
$29/mo
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