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.
FDA Recall Z-2334-2008 · Posted 2008-09-20
Recalling FirmBio-Detek, Inc.
Recall StatusTerminated
Product CodeMLN
Date Initiated2008-06-16
Date Terminated2016-05-10
Product Quantity25 cases of 8/cs for each lot # ; Total of 400 units
Reason for Recall
Multi-function electrode programmed as a Pediatric instead of Adult
Firm Action
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
Distribution Pattern
MA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.