BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950).
This recall has been terminated (originally issued March 2, 2010).
- Company
- Smiths Medical Pm, Inc. N7
- Recall Initiated
- January 15, 2010
- Posted
- March 2, 2010
- Terminated
- March 14, 2012
- Recall Number
- Z-0919-2010
- Quantity
- 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)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Power cord # WW3005.
Root Cause
Nonconforming Material/Component
Action Taken
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.