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Class 2 Device Recall Zoll |
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Date Initiated by Firm |
July 30, 2004 |
Date Posted |
August 18, 2004 |
Recall Status1 |
Terminated 3 on January 13, 2005 |
Recall Number |
Z-1380-04 |
Recall Event ID |
29704 |
510(K)Number |
K915159
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Product Classification |
Catheter, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
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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 |
Recalling Firm/ Manufacturer |
Bio-Detek, Inc. 525 Narragansett Park Dr Pawtucket RI 02861-4323
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For Additional Information Contact |
Robert Morse 866-639-0060 Ext. 224
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Manufacturer Reason for Recall |
Pads may fail due to excessive corrosion of the electrode prior to the expiration date
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DRF and Original Applicant = ZMI CORP.
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