FDA Medical Device Recalls (openFDA)
Bio-Detek, Inc.: 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.
- Recall number
- Z-1011-2012
- Recalling firm
- Bio-Detek, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-12-30
- Posted
- 2012-02-13
- Terminated
- 2012-12-11
- Reason
- Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
- 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
- 3,080 units
- Distribution
- Worldwide Distribution -- US and Canada.
- Lot, serial or model codes
- Lot Numbers 0510 thru 4511
- 510(k) numbers
- ["K072430"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1218058
- Firm city
- Pawtucket
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28