ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.
This recall has been terminated (originally issued September 20, 2008).
- Company
- Bio-Detek, Inc.
- Recall Initiated
- June 16, 2008
- Posted
- September 20, 2008
- Terminated
- May 10, 2016
- Recall Number
- Z-2334-2008
- Quantity
- 25 cases of 8/cs for each lot # ; Total of 400 units
- Firm Location
- Pawtucket, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Multi-function electrode programmed as a Pediatric instead of Adult
Distribution
MA
Lot / Code Info
Lot #'s : 2108 & 2208
Root Cause
Process control
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.
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