Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
FDA device recall Z-1380-04 · posted 2004-08-18 · Terminated
Recall details
- Recalling firm
- Bio-Detek, Inc.
- Reason for recall
- Pads may fail due to excessive corrosion of the electrode prior to the expiration date
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 9.971 pairs
- Distribution
- Nationwide
- Date initiated
- 2004-07-30
- Date posted
- 2004-08-18
- Date terminated
- 2005-01-13
- Location
- Pawtucket, RI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC MULTI-FUNCTION ELECTRODES (K915159) | Zmi Corp. | 1992-02-07 |