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U.S. Department of Health and Human Services

Class 2 Device Recall Smith Medical PM, Inc., BCI MiniTorr Plus NIBP Monitor with SpO2 BuiltIn Printer

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  Class 2 Device Recall Smith Medical PM, Inc., BCI MiniTorr Plus NIBP Monitor with SpO2 BuiltIn Printer see related information
Date Initiated by Firm April 02, 2008
Date Posted August 25, 2008
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-1649-2008
Recall Event ID 47800
510(K)Number K970801  K983796  K984618  K031742  
Product Classification Non-invasive blood pressure monitor - Product Code DXN
Product BCI Non Invasive Blood Pressure Monitor
Product/Catalog number 6004,
Code Information AJ07080009 AJ07080010 AJ07080041 AJ07080042 AJ07110027 AJ07110030 AJ07110031 AJ07080040 AJ07080043 AJ07110000 AJ07110001 AJ07110002 AJ07110003 AJ07110004 AJ07110026 AJ07080039 AJ07080004 AJ07080032 AJ07080033 AJ07080034 AJ07080044 AJ07080045 AJ07080056 AJ07080057 AJ07080058 AJ07110010 AJ07110047 AJ07110048 AJ07110049 AJ07080002 AJ07110009 AJ07110011 AJ07080003 AJ07080005 AJ07080011 AJ07080012 AJ07080013 AJ07080014 AJ07080015 AJ07080016 AJ07080017 AJ07080018 AJ07080019 AJ07080020 AJ07080021 AJ07080022 AJ07080023 AJ07080024 AJ07080025 AJ07080026 AJ07080027 AJ07080028 AJ07080029 AJ07080030 AJ07080031 AJ07080046 AJ07080047 AJ07080035 AJ07080059 AJ07100060 AJ07100073 AJ07110046 AJ07110012 AJ08010000 AJ08010001 AJ07110042 AJ07110043 AJ07110044 AJ07110045 AJ07080048 AJ07110018 AJ07110019 AJ07110020 AJ07110021 AJ07110040 AJ07100002 AJ07100004 AJ07100006 AJ07100009 AJ07100010 AJ07100011 AJ07100012 AJ07100013 AJ07100014 AJ07100015 AJ07100016 AJ07100017 AJ07100018 AJ07100020 AJ07100024 AJ07100025 AJ07100026 AJ07100028 AJ07100029 AJ07100030 AJ07100031 AJ07100034 AJ07100035 AJ07100036 AJ07100038 AJ07100039 AJ07100051 AJ07100058 AJ07100064 AJ07100065 AJ07100000 AJ07100001 AJ07100005 AJ07100007 AJ07100008 AJ07100019 AJ07100021 AJ07100022 AJ07100023 AJ07100027 AJ07100033 AJ07100037 AJ07100045 AJ07100046 AJ07100047 AJ07100048 AJ07100049 AJ07100050 AJ07100052 AJ07100053 AJ07100054 AJ07100055 AJ07100056 AJ07100057 AJ07100059 AJ07100061 AJ07100062 AJ07100063 AJ07100066 AJ07100067 AJ07100068 AJ07100071 AJ07100072 AJ07100003 AJ07100032 AJ07110014 AJ07110015 AJ07110038 AJ07080036 AJ07080053 AJ07080054 AJ07080055 AJ07100070 AJ07080006 AJ07080007 AJ08010004 AJ07110016 AJ07110017 AJ07110013 AJ07110039 AJ07110041 AJ07110022 AJ07110023 AJ07080051 AJ07100040 AJ07100041 AJ07100042 AJ07110024 AJ07110005 AJ07110006 AJ07110007 AJ07110008 AJ07080052 AJ07100069 AJ07100074 AJ07080008 AJ07100043 AJ07100044 AJ07110032 AJ07110033 AJ07110034 AJ07110035 AJ07110036 AJ07110037 
Recalling Firm/
Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha WI 53186-1856
For Additional Information Contact
Manufacturer Reason
for Recall
Due to a component that may be installed backwards, the device may turn off or may immediately reset.
FDA Determined
Cause 2
Employee error
Action Consignees were contacted on 4/2/08 with a Safety Action Bulletin, 08-SAB02, and Technical Worksheet 08-TW01 dated April 1, 2008, which included information regarding the potential safety issue and the proper inspection method for the monitor(s). If you have not received the Safety Action Bulletin or the Technical Worksheet contact Smiths Medical PM, Inc. at Telephone: (262) 542-3100 or Toll Free: (USA): (800) 558-2345 or email info.pm@smiths-medical.com.
Quantity in Commerce 195
Distribution USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR. OUSA: Argentina, Canada, Ecuador, Greece, Hong Kong, Italy, Pakistan, Peru, Russia, saudi Arabia, Slovakia, Thailand, United Kingdom
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = BCI INTL., INC.
510(K)s with Product Code = DXN and Original Applicant = BCI, INC.