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August 2010 vol. 19:12

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

Class I – CARDIAC SCIENCE CORPORATION, Bothell, Washington: Manufacturer: Cardiac Science Corporation, Deerfield, Wisconsin. Defibrillator: Automated External Defibrillators: a) Cardiac Science – Powerheart AED G3, Models: 9300 A, C, D, E, P, and 9390 A and E; b) Burdick 3 Cardiovive Models: 92332, 92533; c) GE – 2 Responder Models: 2019198, 2023440; d) NK 2 CardioLife Models: 9231, and 9200G. Class I. Firm initiated recall ongoing. Firm first notified users by letter dated October 2009. Volume in Commerce: 1,171 devices (569 nationwide and 602 internationally. Reason: Certain Models of Powerheart G3 AED s may not have received adequate electrical safety testing prior to being shipped from the factory. FDA recalls #Z-1424-2010. FDA Enforcement Report, 08/11/10.

Class I – IKARIA HOLDINGS, Clinton, New Jersey: Manufacturer: INO Therapeutics, Middleton, Wisconsin. INOMAX DS Drug Delivery System: provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. Class I. Firm initiated recall ongoing. Firm first notified users by letter dated July 21, 2010. Volume in Commerce: 2,507 units. Reason: The pressure switch in the IOMAX DS drug delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation of patients. FDA recall #Z-2176-2010. FDA Enforcement Report, 08/18/10.

Class I – Update – PHYSIO-CONTROL, INC., Redmond, Washington. Defibrillator/Monitor:LIFEPAK 15. Class I. Firm initiated recall ongoing. Firm first notified users by letter on March 2010. Volume in Commerce: 3,609 devices (1,242 nationwide and 2,159 internationally). Reason: Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn’t turn off. FDA recall #Z-1410-2010; MEDWATCH: April 22, 2010; Around the Circuit, April, 2010 – vol 19:05. FDA Enforcement Report, 08/11/10.

Class I – TELEFLEX MEDICAL, Durham, North Carolina: Manufacturer: Teleflex Medical, Perak, Malaysia. Hudson RCI AQUA+ Flex Hygroscopic Condenser Humidifier. Class I. Firm initiated recall ongoing. Firm first notified users by letter on March 22, 2010. Volume in Commerce: 48,078 units: California, Florida, Georgia, Illinois, Kentucky, Kansas, Massachusetts Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin, and Japan. Reason: The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-arrest. FDA recall #Z-1634-2010. FDA Enforcement Report, 08/18/10.

MINDRAY DS USA, INC., dba Datascope Patient Monitoring, Mahwah. New Jersey. Passport V Monitor: for use with reusable temperature probes and monitors. Class II. Firm initiated recall is ongoing. Firm notified users by letters beginning April 28, 2010. Volume in Commerce: 41 units: Arizona, Florida, Illinois, Missouri, New York, Tennessee, Texas, & Ohio international. Reason: An issue has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational. FDA recall #Z-1785-2010. FDA Enforcement Report, 08/11/10.

MINNTECH CORPORATION, Plymouth, Minnesota. DSD Application Guide: for the Pentax Universal Video Scope Hookup only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U. Class II. Firm initiated recall is ongoing. Firm first notified users by letter dated July 17, 2010. Volume in Commerce: 185 units. Reason: The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinted DSD hookup Application Guide (M04-0001 revision M). FDA recall #Z-2213-2010. FDA Enforcement Report, 08/18/10.

NOVA BIOMEDICAL CORPORATION, Waltham, Massachusetts. Nova StatStrip Glucose Test Strips. Class II. Firm initiated recall ongoing. Firm first notified users by telephone and follow up by email and/or fax dated February 12, 2010. Volume in Commerce: 392 cases (1800 strips per case) – 705,600 strips: Colorado, Massachusetts, Minnesota, Rhode Island plus international. Reason: Glucose strips report low glucose results. FDA recall #Z-1783-2010. FDA Enforcement Report, 08/11/10.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. AC Power Cords: Manufactured by Electri-Cord with tall bridge designs; used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novametrix or Respironics/Novametrics products, & Philips HeartStart MRx Defibrillator/monitor M3535A. Class II. Firm initiated recall ongoing. Firm notified users by telephone beginning November 20, 2009. Volume in Commerce: 37,997 units nationwide and internationally including 53 product models. Reason: Power cords’ prongs may crack or fail – Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Co power cords used with medical devices may be defective in that the power cord’s prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock. FDA recalls #Z-1257/1309-2010. FDA Enforcement Report, 08/11/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO., Phillips, Bothell, Washington. X-Ray: 1) DigitalDiagnost General Radiology; 2) BuckyDiagnost General Radiology and Tomo, 3) EasyDiagnost Multi-functional R/F Systems. Class II. Firm initiated recall ongoing. Firm notified users by letters dated January 20 & 21, 2010. Volume in Commerce: 118 units. Reason: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording. FDA recalls #Z-0847/0849-2010. FDA Enforcement Report, 08/11/10.

SIEMENS MEDICAL SOLUTIONS, USA, INC., Malvern, Pennsylvania: Manufacturer: Siemens Medical Solutions, INC., Erlanger, Germany. X-Ray: Axiom Artis System with Motor Controller Unit, intended for x-ray, angiographic use. Class II. Firm initiated recall ongoing. Firm first notified users by letter on April 12, 2010. Volume in Commerce: 83 units. Reason: Sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts might increase during the lifetime of the system. FDA recall #Z-1732-2010. FDA Enforcement Report, 08/11/10.

SONOSITE, INC., Bothell, Washington. Sonosite TEE, 8-3 MHz Transducer. Class II. Firm initiated recall complete. Firm first notified users by letter on August 21, 2008. Volume in Commerce: 357 units. Reason: The TEE transesophageal transducer, when connected to a Sonosite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array. FDA recall #Z-2191-2010. FDA Enforcement Report, 08/18/10.

SMITHS MEDICAL ASD, INC., Saint Paul, Minnesota. Medfusion Syringe Infusion Pump: Models 3010 and 3010a with Software versions 2.0.2., 2.0.3, and 2.0.4. Class II. Firm initiated recall ongoing. Firm notified users by letters dated June 11, 2010. Volume in Commerce: 4,816 units. Reason: Pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has not received reports of serious patient injury or death. FDA recall #Z-2121-2010. FDA Enforcement Report, 08/11/10.

STRYKER ENDOSCOPY, San Jose, California. Crossfire Console. Class II. Firm initiated recall ongoing. Firm notified users by letters dated June 28, 2010, and July 9, 2010. Volume in Commerce: 989 units – nationwide and internationally. Reason: RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot Switch. FDA recall #Z-2193-2010. FDA Enforcement Report, 08/18/10.