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Class 2 Device Recall BioMed Devices |
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Date Initiated by Firm |
November 07, 2003 |
Date Posted |
January 06, 2004 |
Recall Status1 |
Terminated 3 on February 01, 2016 |
Recall Number |
Z-0300-04 |
Recall Event ID |
27937 |
Product Classification |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use - Product Code MNT
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Product |
MVP-10 Pediatric/ Neonatal Volume Ventilator |
Code Information |
S/N: 3023031, 3025031, 0957951 |
Recalling Firm/ Manufacturer |
Bio-Med Devices, Inc. 1445 Boston Post Rd Guilford CT 06437-4338
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For Additional Information Contact |
Ken Close 203-458-0202 Ext. 17
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Manufacturer Reason for Recall |
Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
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FDA Determined Cause 2 |
Other |
Action |
Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction. |
Quantity in Commerce |
3 units |
Distribution |
ID, PA, TX |
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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