Recall Z-0918-2010 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Smiths Medical PM, Inc.
9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).
| Date | Mar 2, 2010 (initiated Jan 15, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root 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 |
| Quantity | 1358 cords for all devices (1032 US, 326 OUS) (871 Human, 487 Vet), (Cord # 8404 5 Vet & 325 Human), (Cord # WW3005 482 |
| 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, Canad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030407 | ADVISOR, MODEL 9200 Bci, Inc., Aug 19, 2003 |