FDA Medical Device Recalls (openFDA)
Bio-Detek, Inc.: Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
- Recall number
- Z-1380-04
- Recalling firm
- Bio-Detek, Inc.
- Product
- Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
- Status
- Terminated
- Initiated
- 2004-07-30
- Posted
- 2004-08-18
- Terminated
- 2005-01-13
- Reason
- Pads may fail due to excessive corrosion of the electrode prior to the expiration date
- Root cause
- Other
- Action
- Biotek notified Zoll Medical Corp Zoll notified their customers by letter dated 7/28/04. Users are requested to discard electrodes and return an acknowledgement form. Recalled product will be replaced.
- Quantity
- 9.971 pairs
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 3103, 3203, 3303, 3403, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303
- 510(k) numbers
- K915159
- PMA numbers
- not on file
- Product code
- DRF
- 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