Class 2 Device Recall Zoll

• Date Initiated by Firm: July 30, 2004
• Date Posted: August 18, 2004
• Recall Status: Terminated on January 13, 2005
• Recall Number: Z-1380-04
• Recall Event ID: 29704
• 510(K)Number: K915159
• Product Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
• Product: Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065
• Code Information: Lot Numbers: 3103, 3203, 3303, 3403, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303
• FEI Number: 1218058
• Recalling Firm/ Manufacturer: Bio-Detek, Inc.; 525 Narragansett Park Dr; Pawtucket RI 02861-4323
• For Additional Information Contact: Robert Morse; 866-639-0060 Ext. 224
• Manufacturer Reason for Recall: Pads may fail due to excessive corrosion of the electrode prior to the expiration date
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 9.971 pairs
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DRF