Z-1011-2012

Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with...

Name: Z-1011-2012 Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with...
Creator: Bio-Detek, Inc.
Published: 2011-12-30
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2011-12-30 / Terminated / root cause: manufacturing process

FDA source

Bio-Detek, Inc. began a recall of Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Series and E series Defibrillators... on 2011-12-30. The reason FDA records is "Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1011-2012
Status: Terminated
Initiated: 2011-12-30
Posted: 2012-02-13
Terminated: 2012-12-11
Recalling firm: ZOLL Medical Corporation
Product: 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.
Reason for recall: Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 3,080 units
Distribution: Worldwide Distribution -- US and Canada.
Product codes and lots: Lot Numbers 0510 thru 4511

K072430Class IIIZoll Pedipadz Reduced Energy ElectrodeZOLL Medical Corporation / cleared 2007-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)