Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Seri
FDA device recall Z-1011-2012 · posted 2012-02-13 · Terminated
Recall details
- Recalling firm
- Bio-Detek, Inc.
- Reason for recall
- Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
- Action taken
- Zoll Medical issued Urgent Device Correction notices dated 12/30/11 via UPS/Registered Mail. The letter described the issue and identified the affected product. ZOLL recommended that customers alert their staff of the issue, that the electrodes should be kept away from a fluid environment, to use caution in handling the electrodes if they are subjected to a fluid environment and maintain safe defibrillation practice, and seek a replacement if available. Also customers should contact Zoll 1-800-348-9011 for product replacement. The firm plans to replace the affected lots free of charge.
- Root cause
- Process control
- Status
- Terminated
- Quantity affected
- 3,080 units
- Distribution
- Worldwide Distribution -- US and Canada.
- Date initiated
- 2011-12-30
- Date posted
- 2012-02-13
- Date terminated
- 2012-12-11
- Location
- Pawtucket, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE (K072430) | ZOLL Medical Corporation | 2007-11-06 |