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Modern Biomedical

June 2011 - vol. 20:08

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.

Update -- Class I: DEFIBTECH, L.L.C., Guilford, Connecticut. Defibrillator- AED: 1) Lifeline DDU-100; b) ReviveR DDU-100. Class I. Volume in Commerce: 91,472 units. Firm notified users in February 2011 and FDA notified users by Medwatch Press Release and recall in March 2011 and posted in May. Reason: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. FDA recall #Z-2064-2011. FDA Enforcement Report, 06/01/11. Vol. 20:08.

Class I: PHILIPS HEALTHCARE INC., Andover, Massachusetts: Manufacturers: Philips Medizen Systeme Boblingen Gmbh, Boblingen, Germany; Oridon Medical 1987 Ltd., Jerusalem, Israel. Filters Used w/Philips Monitors: 1)Philips Microstream, Model M1923A FILTERLILNE H SET INF/NEO 25UN PHILIPS; 2) Philips Microstream, Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS. Class I. Firm initiated recall ongoing. Firm notified users by letter dated April 2011. Volume in Commerce: 1,025 units. Reason: Fine plastic strands on inner surface of the infant/neonatal airway adapter may become dislodges and inhaled by the patient. FDA recalls #Z-2247/2248-2011. FDA Enforcement Report, 06/15/11. Vol. 20:08.

Intra-Aortic Balloon Pumps Recall:

Datascope/Maquet S90/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps

FDA – For immediate release - June 6, 2011 - In March 2011, Datascope Corp/Maquet initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 ( Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names. Customers who have 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT, CS100/CS100i and CS300 IABP brand names which are being recalled may schedule a visit by a Service Representative by contacting the US Call Center at 1-800-777-4222, Press 3.

A total of 840 US customer IABPs and 453 international customer IABPs are affected by this field correction. Between May 2008 and December 2010 specific System 98/98XT, CS100/CS100i and CS300 IABPs were manufactured with an affected power supply, or may have received an affected power supply during an upgrade/service of the IABP in the field. In specific units, the fan assembly of the power supply could potentially contain a misshapen retaining ring. This retaining ring could disengage within the fan, causing the fan blade assembly to stop rotating. Consequently, the power supply would detect an overheating event, and shut down without visual or audible alarms. The data to date indicates that there is a very small likelihood for an IABP to contain a misshapen retaining ring. This device failure may result in unanticipated interruption of counterpulsation therapy.

The U.S. Food and Drug Administration ("FDA") has classified this action as a Class 1 recall. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Datascope Corp/Maquet initiated the field correction in March 2011 and at that time notified all customers that may have an IABP affected by this field correction. The corrective action associated with this field correction is to provide an upgraded power supply to all IABPs containing an affected power supply. A Service Representative will conduct the upgrade and document this corrective action during a visit to the customer. To date, 55% of US customer units have been completed and every effort is being made to complete all affected domestic IABPs as soon as possible. For additional information, contact Technical Support at 1-800-777-4222.

ABBOTT POINT OF CARE, Nepean Ontario, Canada. i-STAT CHEM 8+ Cartridge. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated February 2011.Volume in Commerce: 6,575 cartridges.Reason: Cartridge may generate false results for sodium, chloride, and hemomatricrit. FDA recall #Z-2022-2011. FDA Enforcement Report, 06/15/11. Vol. 20:08.

BAXTER HEALTHCARE CORP., Round Lake, Illinois: Manufacturer: Baxter Healthcare SA, Singapore. Infusion Pump – Colleague, Colleague CX, and CXE Infusion Pumps. Class II. FDA initiated recall is ongoing. Firm notified users by telephone on April 14, 2011 and by letter dated April 27, 2011. Volume in Commerce: 117 units.Reason: The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user. FDA recall #Z-2222-2011. FDA Enforcement Report, 05/25/11. Vol. 20:08.

INTEGRA LIFESCIENCES CORP., Plainsboro, New Jersey: Manufacturers: Integra Radionics Inc., Burlington, Mississippi; Integra Luxtec, Inc., West Boylston, Massachusetts. Light Source: Luxtex MLX 300 Watt Xenon Light Source, Model OOMLX. Class II. Firm initiated recall is ongoing; firm notified users by letter dated March 8, 2011. Volume in Commerce: 159 units. Reason: Malfunction of the MLX Control Board may cause loss of manual control and lamp shut down. FDA recall #Z-2060-2011. FDA Enforcement Report, 06/01/11. Vol. 20:08.

INTEGRA LIFESCIENCES CORP., Plainsboro, New Jersey: Manufacturer: LifeSciences Corp., Cincinnati, Ohio. Power Supply Units: Part # DP0007 and DP0800 for use with the Integra Padgett Dermatomes – Models S, SB, and S6. Class II. Firm initiated recall is ongoing; firm notified users by telephone on March 10, 2011 and letters on March 11, 2011. Volume in Commerce: 1,047 units. Reason: Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient. FDA recall #Z-2225-2011. FDA Enforcement Report, 06/01/11. Vol. 20:08.

MEDELA INC., McHenry, Illinois. AC Power Adapter (transformer): TENPAO Model U090100Q31 – used with Pump In Style Advanced family of breast pumps; Made in China. Class II. FDA initiated recall is ongoing; firm notified users by letter dated April 4, 2011 Volume in Commerce: 17,681 units alone – 461,142 units with product. Reason: The power adapter (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged in not properly handled. FDA recall #Z-2386-2011. FDA Enforcement Report, 06/08/11. Vol. 20:08.

PHILIPS MEDICAL SYSTEMS NEDERLANDS, BEST, NETHERLANDS: Manufacturer: Philips Medical Systems North America Co. Philips, Bothell, Washington. TEE Transducer: S8-3t Micro. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 28, 2011. Volume in Commerce: 155 units. (76 in US) . Reason: Users reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients. FDA recall #Z-2062-2011. FDA Enforcement Report, 06/08/11. Vol. 20:08.

RESPIRONICS NOVAMETRIX, LLC., Wallingford, Connecticut. 1) Philips NM3 Monitors; 2) Philips FloTrak Elite Modules. Class II. Firm initiated recall is ongoing. Firm notified users by letter on January 4, 2011. Volume in Commerce: 220 units. Reason: Software: two displayed respiratory parameters are incorrect due to errors in the system software. FDA recalls #Z-2167/2168-2011. FDA Enforcement Report, 05/25/11. Vol. 20:08.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound System: ACUSON S2000. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 15, 2011. Volume in Commerce: 1,533 units. Reason: Firm discovered a software error affecting the measurement results in the patient report. FDA recall #Z-2051-2011. FDA Enforcement Report, 06/08/11. Vol. 20:08.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC., Tustin, California. Cardiovascular Fluoroscopy: 1) Toshiba Infinix-i, INFX-8000C; 2) Infinix-i, INFX-8000F; 3) Infinix-i, INFX-8000V; 4) Infinix-i , DFP-8000D. Class II. Firm initiated recall ongoing. Firm notified users by letter beginning December 21, 2010. Volume in Commerce: 220 units. Reason: Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value. FDA recalls #Z-1871/1874-2011. FDA Enforcement Report, 06/15/11. Vol. 20:08.

ZOLL MEDICAL CORPORATION. Chelmsford, Massachusetts. Defibrillator: Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11. Class II. Firm notified users by letter on April 22, 2011. Volume in Commerce: 874 units. Reason: The device may fail to auto charge and deliver energy. FDA recall #Z-2294-2011. FDA Enforcement Report, 06/01/11. Vol. 20:08.