Z-0920-2010

8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA...

Name: Z-0920-2010 8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA...
Creator: Smiths Medical PM, Inc.
Published: 2010-01-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-01-15 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical PM, Inc. began a recall of 8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330 on 2010-01-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0920-2010
Status: Terminated
Initiated: 2010-01-15
Posted: 2010-03-02
Terminated: 2012-03-14
Recalling firm: Abbott Medical
Product: 8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Power cord # 8404.

Product code CCK

K991086Class IICapnocheck II, Model 8400Bci Intl., Inc. / cleared 1999-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)