Class 2 Device Recall BCI 3180 Pulse Oximeter

• Date Initiated by Firm: January 15, 2010
• Date Posted: March 02, 2010
• Recall Status: Terminated on March 14, 2012
• Recall Number: Z-0919-2010
• Recall Event ID: 54360
• 510(K)Number: K020350
• Product Classification: Oximeter - Product Code DQA
• Product: BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950).
• Code Information: Power cord # WW3005.
• Recalling Firm/ Manufacturer: Smiths Medical PM, Inc.; N7 W22025 Johnson Dr; Waukesha WI 53186-1856
• For Additional Information Contact: 262-542-3100
• 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: 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 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 = DQA