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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Pneupac babyPAC 100

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 Class 2 Device Recall Smiths Pneupac babyPAC 100see related information
Date Initiated by FirmDecember 05, 2005
Date PostedJanuary 24, 2006
Recall Status1 Terminated 3 on December 26, 2006
Recall NumberZ-0436-06
Recall Event ID 34275
Product Classification Ventilator, Emergency, Powered (Resuscitator) - Product Code BTL
ProductSmiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.
Code Information 0504244, 0505158, 0506211, 0506218, 0506242, 0506248, 0506254, 0506265, 0506283, 0506289, 0506321, 0506346, 0506358, 0507127, 0507139, 0507234, 0507235, 0507236, 0507248, 0507249, 0507265, 0508173, 0508174, 0508195, 0508196, 0508197, 504227, 504254, 505139, 505142, 505145, 505257, 505271, 505276, 505286, 506155, 506158, 506169, 506171, 506194, 506233, 506241, 506343, 507317
Recalling Firm/
Manufacturer		 Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha WI 53186-1856
Manufacturer Reason
for Recall		A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
FDA Determined
Cause 2		Other
ActionConsignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair.
Quantity in Commerce44
DistributionCA, CO, IN,MN, NY, PA, TN, 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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