ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the followi
FDA device recall Z-2334-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Bio-Detek, Inc.
- Reason for recall
- Multi-function electrode programmed as a Pediatric instead of Adult
- Action taken
- Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided. Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MLN
- Quantity affected
- 25 cases of 8/cs for each lot # ; Total of 400 units
- Distribution
- MA
- Date initiated
- 2008-06-16
- Date posted
- 2008-09-20
- Date terminated
- 2016-05-10
- Location
- Pawtucket, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES (K051076) | ZOLL Medical Corporation | 2005-05-13 |