Bio-Detek, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Bio-Detek, Inc.
Lot Codes / Batch Numbers
Lot #'s : 2108 & 2208
Products Sold
Lot #'s : 2108 & 2208
Bio-Detek, Inc. is recalling ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indi due to Multi-function electrode programmed as a Pediatric instead of Adult. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Multi-function electrode programmed as a Pediatric instead of Adult
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA
Page updated: Jan 10, 2026