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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 – HOSPIRA INC., Morgan Hill, California. Infusers: a) Symbiq One-Channel Infuser b) Symbiq Two-Channel Infuser. Class I. Firm initiated recall ongoing. Firm first notified users by letter dated June 11, 2010. Volume in Commerce: 28,485 devices. Reason: Hospira has received numerous customer complaints of the Symbiq Infusion pump’s failure to detect air-in-line conditions during operation. FDA recalls #Z-1894/1895-2010. FDA Enforcement Report, 07/14/10.
Class I – PHYSIO-CONTROL, INC., Redmond, Washington. Defibrillator/Monitor:LIFEPAK 20/20e. Class I. Firm initiated recall ongoing. Firm first notified users by letters on May 26, 2010. Volume in Commerce: 42,943 devices distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007. Reason: A failure on the power supply assembly can result in either “No DC power” or “No DC or AC power”. A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate. Contact Physio-Control Technical Support at email@example.com or call 1-800-442-1142, Monday – Friday between 6:00 A.M. and 4:00 P.M. (Pacific Time). FDA Comments: The firm began mailing notification letters to affected customers on May 26, 2010. All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. FDA recall #Z-1903-2010. FDA Enforcement Report, 07/14/10
CARDIAC SCIENCE CORPORATION, Bothell, Washington: Manufacturer: Cardiac Science Corporation, Deerfield, Wisconsin. Defibrillators: Powerheart 9390A AED. Class II. Firm initiated recall is ongoing. Firm notified users by letters between December 18 and December 23, 2009. Volume in Commerce: 332 units. Reason: The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy. FDA recall #Z-1810-2010. FDA Enforcement Report, 07/14/10.
CARDIAC SCIENCE CORPORATION, Bothell, Washington: Manufacturer: Cardiac Science Corporation, Deerfield, Wisconsin. Treadmills: Models TM55, TM65, and CR60. (Brand names include Quinton, Burdick, and Cardiac Science). Class II. Firm initiated recall is ongoing. Firm notified users by letter April 3, 2009. Volume in Commerce: 28 units. Reason: 28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. Because safety testing may not have allowed for complete evaluation of the electrical isolation of the treadmill, there is a remote chance a shock hazard could exist. FDA recall #Z-1757-2010. FDA Enforcement Report, 07/14/10.
DATASCOPE CORPORATION, Fairfield, New Jersey: Manufacturer: Maquet Datascope Corporation –Cardiac Assist Division, Mahwah, New Jersey. Balloon Pump (IABP): a) CS100 Intra-Aortic Balloon Pump; b) CS300 Intra-Aorta Balloon Pump; c) System 98XT/98 Intra-Aorta Balloon Pump – model distributed internationally only. Class II. Firm initiated recall is ongoing. Firm notified users by letter beginning May 10, 2010. Volume in Commerce: 161 units. Reason: Certain IABP s have the potential to experience display relate issues. Although the device continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen. FDA recalls #Z-1811/1813-2010. FDA Enforcement Report 07/14/10.
MEDTRONIC CARDIOVASCULAR REVASCULARIZATION & SURGICAL THERAPY, Brooklyn, New York: Manufacturer: Electri-Cord Manufacturing Co. Hospital Grade Power Cord: detachable unit, supplied with Medtronic Bio-Console 550, 560, Medtronic autoLog, and Medtronic Sequestra 1000 since 2003. Class II. Firm initiated recall is ongoing. Firm notified users by letters dated April 19, 2010. Volume in Commerce: 699 units. Reason: The power cord’s prongs may crack and fall at/or inside the plug. FDA recall #Z-1939-2010. FDA Enforcement Report, 07/07/10.
ROMEDIC, INC., Ephrata, Pennsylvania: Manufacturer: Romedic AB, Jarfalla, Sweden. Battery Charger: for EVA 450 Patient Lift. Class II. Firm initiated recall is ongoing. Firm notified users by letters April 28, 2010. Volume in Commerce: 76 units. Reason: Incorrect battery chargers were supplied with the EVA 450 Patient Lifts. Charger unit stops working and will not charge it. New chargers supplied to customers. FDA recall #Z-1736-2010. FDA Enforcement Report, 07/14/10.
STERIS CORPORATION, Mentor, Ohio: Manufacturer: Steris Corporation, Montgomery, Alabama. Surgical Table: Model # 4085, 5085 & 5085SRT. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated May 14, 2010. Volume in Commerce: 79 units. Reason: A limited quantity of the manifold assemblies were manufactured with incorrect washers and springs in the valves of the manifold. This error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table sections move slowly or drift without prompting by an operator. FDA recall #Z-1941-2010. FDA Enforcement Report, 07/07/10.
FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall: Company must provide transition guide for facilities using Colleague infusion pumps
The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination.
Baxter is responsible for recalling as many as 200,000 CVIP currently in use in the United States. Under the FDA’s requirements, Baxter will also provide a transition guide to assist customers affected by the recall. The guide will include a list of FDA-cleared or approved pump alternatives, suggestions to help minimize disruption and patient risk during the transition period, and detailed information on the refund, replacement, and lease termination programs.
“FDA is requiring Baxter to provide replacements or refunds for these recalled devices,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “This action reflects the agency’s commitment to protect patients by removing unsafe infusion pumps and to promote public health through assuring the availability of safe and effective alternatives.”
Baxter will continue to provide batteries, spare parts, and service for the affected pumps during the transition period for customers who submit a Certificate of Medical Necessity to Baxter. The certificate, provided by Baxter, asks for information such as the number of CVIP currently in use, serial numbers, and the anticipated date that the CVIP will be removed from use. After receiving the completed certificate, Baxter will continue service for 24 months after today’s date, or until the customer has transitioned to another pump.
Baxter will complete the recall and the replace or refund programs by July 14, 2012.
“Baxter’s Colleague infusion pumps are commonly found in many hospitals and facilities,” said Dr. Shuren. “Considering the size of the recall the FDA reached out directly to the hospital community in order to determine what would best fit their needs in a transition plan.”
The FDA has been working with Baxter since 1999 to correct numerous flaws in the CVIP, that have been the subject of several Class I recalls for battery failures, inadvertent powering off, service data errors, and other issues.
In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the CVIP until the company corrected manufacturing deficiencies and brought the pumps into compliance with the law.
On April 8, 2010, Baxter submitted a proposed correction schedule for the CVIP that the FDA found unacceptable. The FDA ordered the recall and replace or refund action pursuant to the authority granted to the agency by the 2006 consent decree.