Z-1380-04

Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065

Name: Z-1380-04 Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
Creator: Bio-Detek, Inc.
Published: 2004-07-30
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2004-07-30 / Terminated

FDA source

Bio-Detek, Inc. began a recall of Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065 on 2004-07-30. The reason FDA records is "Pads may fail due to excessive corrosion of the electrode prior to the expiration date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1380-04
Status: Terminated
Initiated: 2004-07-30
Posted: 2004-08-18
Terminated: 2005-01-13
Recalling firm: ZOLL Medical Corporation
Product: Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Pads may fail due to excessive corrosion of the electrode prior to the expiration date
FDA 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 in commerce: 9.971 pairs
Distribution: Nationwide
Product codes and lots: Lot Numbers: 3103, 3203, 3303, 3403, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303

Product code DRF

K915159Class IIPediatric Multi-Function ElectrodesZmi Corp. / cleared 1992-02-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)