Date Initiated by Firm |
December 30, 2011 |
Date Posted |
February 13, 2012 |
Recall Status1 |
Terminated 3 on December 11, 2012 |
Recall Number |
Z-1011-2012 |
Recall Event ID |
60835 |
510(K)Number |
K072430
|
Product |
Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401
Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. |
Code Information |
Lot Numbers 0510 thru 4511 |
Recalling Firm/ Manufacturer |
Bio-Detek, Inc. 525 Narragansett Park Dr Pawtucket RI 02861-4323
|
For Additional Information Contact |
401-729-1400
|
Manufacturer Reason for Recall |
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
|
FDA Determined Cause 2 |
Process control |
Action |
Zoll Medical issued Urgent Device Correction notices dated 12/30/11 via UPS/Registered Mail. The letter described the issue and identified the affected product. ZOLL recommended that customers alert their staff of the issue, that the electrodes should be kept away from a fluid environment, to use caution in handling the electrodes if they are subjected to a fluid environment and maintain safe defibrillation practice, and seek a replacement if available. Also customers should contact Zoll 1-800-348-9011 for product replacement. The firm plans to replace the affected lots free of charge. |
Quantity in Commerce |
3,080 units |
Distribution |
Worldwide Distribution -- US and Canada. |
|
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 = and Original Applicant = ZOLL MEDICAL CORPORATION
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