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U.S. Department of Health and Human Services

Class 2 Device Recall BioMed Devices

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 Class 2 Device Recall BioMed Devicessee related information
Date Initiated by FirmNovember 07, 2003
Date PostedJanuary 06, 2004
Recall Status1 Terminated 3 on February 01, 2016
Recall NumberZ-0300-04
Recall Event ID 27937
Product Classification Sv70 Ventilator - Product Code MNT
ProductMVP-10 Pediatric/ Neonatal Volume Ventilator
Code Information S/N: 3023031, 3025031, 0957951
FEI Number 3003952420
Recalling Firm/
Manufacturer		 Bio-Med Devices, Inc.
1445 Boston Post Rd
Guilford CT 06437-4338
For Additional Information ContactKen Close
203-458-0202 Ext. 17
Manufacturer Reason
for Recall		Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
FDA Determined
Cause 2		Other
ActionBio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction.
Quantity in Commerce3 units
DistributionID, PA, TX
Total Product Life CycleTPLC 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.
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