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U.S. Department of Health and Human Services

Class 2 Device Recall 9200 Advisor Vital Signs Monitor

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 Class 2 Recall
9200 Advisor Vital Signs Monitor
see related information
Date Posted March 02, 2010
Recall Status1 Terminated on March 14, 2012
Recall Number Z-0918-2010
Recall Event ID 54360
Premarket Notification
510(K) Number
K030407 
Product Classification Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
Product 9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).
Code Information Power cord # WW3005.
Recalling Firm/
Manufacturer
Smiths Medical PM, Inc.
N7 W22025 Johnson Dr
Waukesha, Wisconsin 53186-1856
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were sent a Smiths Medical PM, Inc letter dated January 12, 2010 starting on 1/15/10. The letter was addressed to Risk/Safety Managers, Distributors, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists, and Nursing, Clinical/Biomedical Engineering, and Anesthesia Professionals. The letter described the problem and products involved. It provided "Advice on Action to be Taken by the User" and requested the return of the "Urgent Recall Notice Confirmation Form." Customers are advised to monitor affected equipment. To return Power Cords, for questions regarding this Urgent Recall Notice, or to report any issues with these Power Cords, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.
Quantity in Commerce 1358 cords for all devices (1032 US, 326 OUS) (871 Human, 487 Vet), (Cord # 8404 5 Vet & 325 Human), (Cord # WW3005 482 Vet & 546 Human)
Distribution US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY. Worldwide distribution: Trinidad and Tobago, Mexico, Taiwan, Ecuador, Norway, Colombia, Brazil, France, Japan, Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CCK and Original Applicant = BCI, INC.
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