Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients.
FDA Recall Z-1011-2012 · Posted 2012-02-13
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Recalling FirmBio-Detek, Inc.
Recall StatusTerminated
Date Initiated2011-12-30
Date Terminated2012-12-11
Product Quantity3,080 units
Reason for Recall
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
Firm Action
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
Distribution Pattern
Worldwide Distribution -- US and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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