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October 2010 vol. 19:14

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.

FDA MEDWATCH Postings:10/15/2010

a) Class I CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy - Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.

If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death. These devices were manufactured from December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010.

San Diego-based CareFusion said it informed customers of the recall Aug. 24 in a letter to customers stating that "under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen." The failure could result in a delay of therapy to a patient and prevent caregivers from making programming changes to any current drug infusion, a situation that could cause serious injury or death. CareFusion posted information and instructions regarding the mitigation of the risk on its website

RECOMMENDATION: If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned. This recall affects approximately 17,000 devices.

b) Class I Excelsior Medical Recall of 5 ml Fill in 6 cc Prefilled Saline Flush Syringes

Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility. Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death. No other Excelsior Medical pre-filled saline syringe product codes are affected by this recall.

BACKGROUND: The Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringes are intended for the flushing of venous access devices and IV tubing.

RECOMMENDATION: Consumers who have 5ml fill in 6 cc saline pre-filled syringes manufactured by Excelsior Medical should immediately discontinue using these syringes and return them to the point of purchase.

Instructions to Customers

Excelsior Medical Corporation has notified its distributors and customers by letter and is arranging for return/destruction and reimbursement of any products that are returned as a result of this recall. For more information, consumers may contact the company at 1-800-487-4276, by fax at 1-866-688-3185 or e-mail at recall10@excelsiormedical.com.

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DRAGER MEDICAL SYSTEMS, INC., Telford, Pennsylvania. Patient Monitor: 1) Infinity Delta/Gamma X XL catalog # MS18597; 2) Infinity Delta/Gamma X XL catalog # MS18852. Class II. Firm initiated recall ongoing. Firm first notified users by letter on June 4, 2010. Volume in Commerce: 9,475 units. Reason: Monitor keys may become inoperative or activate spontaneously. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. FDA recalls #Z-2283/2284-2010. FDA Enforcement Report, 9/29/10.

HOSPIRA, INC., Morgan Hill, California. Infuser: 1) Symbiq One-Channel Infuser; 2) Symbiq Two-Channel Infuser. Class II. Firm initiated recall ongoing. Firm first notified users by letter dated February 22, 2010. Volume in Commerce: 6,793 units. Reason: The clamp may not secure to the IV pole and the pump may slip off. The pump may fall on a person or pull the tubing out of the IV container. FDA recalls #Z-2390/2391-2010. FDA Enforcement Report, 9/29/10.

MEDTRONIC NAVIGATION, INC., Louisville, Colorado. StealthStation S7 System: Class II. Firm initiated recall ongoing. Firm first notified users by letter June 14, 2010. Volume in Commerce: 199 units nationwide plus 171 internationally. Reason: Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock. FDA recall #Z-2029-2010. FDA Enforcement Report, 10/13/10.

OLYMPUS AMERICA, INC., Center Valley, Pennsylvania: Manufacturer: Shirakawa Olympus Co., Ltd., Nishishirakawa-Gun. Camera Head: OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment). Class II. Firm initiated recall ongoing. Firm first notified users by letter dated August 20, 2010. Volume in Commerce: 217 camera heads. Reason: Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type. FDA recall #Z-2642-2010. FDA Enforcement Report, 10/13/10.


PHILIPS HEALTHCARE, INC.., Andover, Massachusetts: Manufacturer: Philips Medizin Systeme Boblinger Gmbh, Hewlett-Packard Strasse 2, Boblinger, Germany. Anesthesia Gas Modules: 1) M1013A IntelliVue G1 with manifolds; 2) M1019A IntelliVue G5 with manifolds; 3) M1026B IntelliVue with manifolds; 4) M1026BT. Class II. Firm initiated recall ongoing. Volume in Commerce: 4,299 units. Reason: The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels. FDA recalls #Z-2263/2266-2010. FDA Enforcement Report, 09/22/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington. C-arms, Mobile X-Ray with extended rotation option. 1) BV Pulsera System; 2) Endura System. Class II. Firm initiated recall ongoing. Firm notified users by letter dated September 30, 2008. Volume in Commerce: 1,378 units. Reason: The C-arm rotation brake does not always function properly and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions. FDA recalls #Z-2463/2464-2010. FDA Enforcement Report, 09/29/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington: Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Digital/Diagnost X-ray System. Class II. Firm initiated recall complete. Firm notified users by letter dated March 10, 2008. Volume in Commerce: 119 units. Reason: When using DICOM print functionality, the printed images may contain data for the wrong patient. FDA recall #Z-2422-2010. FDA Enforcement Report, 09/22/10.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Arbor, Michigan. Perfusion System: Advanced Perfusion System 1, Catalog number 801763. Class II. Firm initiated recall ongoing. Firm notified users by letter dated September 10, 2010. Volume in Commerce: 2,655 units. Reason: The design documents that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas system. If the user does not recognize that the gas system has failed calibration, and attempts to use the system normally, the FiO2 readings may be inaccurate. The firm received seven complaints related to the oxygen sensor. FDA recall #Z-2480-2010. FDA Enforcement Report, 09/29/10.

3M COMPANY, MEDICAL DIVISION, Saint Paul, Minnesota: Manufacturer: 3M Canada Co., Morden Manitoba, Canada. Monitoring Electrode: Red Dot Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560. Class II. Firm initiated recall ongoing. Firm notified users by letter dated July 29, 2010, Volume in Commerce: 11,063 units. Reason: The sensing element of the electrodes may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response. FDA recall #Z-2383-2010. FDA Enforcement Report, 09/29/10.