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March 2010: vol. 19:03

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 Med Watch: OneTouch SureStep Test Strips (LifeScan): Recall

FOR IMMEDIATE RELEASE: LIFESCAN, INC., Milpitas, California; 2/24/10/PR Newswire. LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death. The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher. MFG Recall, 2/24/10; MedWatch posting: 2/26/10.

Class I – CARDIAC SCIENCE CORPORATION, Bothell, Washington. Defibrillator: Automated External Defibrillators. Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions.

Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. This issue is separate from the Company's November 13 announcement regarding a voluntary medical device correction. Each affected AED should immediately be removed from service since it may not deliver the expected therapy. All affected AEDs will be replaced at no charge to the customer. Cardiac Science will contact customers by letter and will provide them with replacement AEDs as soon as they are available. Replacement shipments were expected to begin February 15. MFG Recall, 2/3/10, FDA MedWatch 2/3/10.

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Class I – STATSPIN, INC., doing business as IRIS Sample Processing, Westwood, Massachusetts. Centrifuge: StatSpin Express 4 Model #510 manufactured and distributed from November 2007 through January 2010. Class I. Firm initiated recall ongoing. On February 3, 2010, the company sent their distributors a letter advising them of the recall and defect. When users return the recalled units, an upgrade kit will be installed to upgrade the unit. If users have a trained technical repair person to install the upgrade kit, the company will send an upgrade kit with instructions. Reason: The rotor of the centrifuge may break and separate from the motor, striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and eject pieces of the rotor. These pieces may cause serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms. MFG Recall, 1/27/10; FDA MedWatch, 02/26/10.

STERIS: Urgent Field Correction

RE: Surgical Lights: Harmony LA, LC 500 and LA 700 Surgical Lighting and Media System. Firm notified users by written notice February 23, 2010. Steris will also contact user/facilities to complete an upgrade to prevent loose wires and/or overheating. Reason: Some customers may experience premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies. In the event of a primary bulb failure, a secondary lamp is automatically activated. Steris refers users to the Operator Manuals and the following recommendations:

1) Do not touch the glass portion of the lamp with bare fingers as this can cause deterioration of material leading to possible failure of the bulbs

2) Use only Steris replacement bulbs

3) Place the lighting system into STANDBY or OFF mode when not in use

Steris may be reached at 800-333-8828.

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HOSPIRA, INC., Morgan Hill, California. AC Power Cords: shipped between 06/2005 and 5/2009. These cords were used on the following pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum XL, Plum XL3, Plum XL3M, Plum XL3D, Plum A+/Plum 3, and Gem Star Docking Stations plus an additional 23 Hospira systems & models. Class II. Firm initiated recall is ongoing. Firm notified users by press release and letter on August 14, 2009. Volume in Commerce: 204,999 units. Reason: Fire/shock hazard – a component used in the device may cause sparks/flashes and poses a fire and shock hazard. FDA recalls #Z-0011/0034-2010. FDA Enforcement Report, 02/24/10.

MAQUET, INC., Bridgewater, New Jersey: Manufacturer: Maquet S.A., Orleans Cedex 2, France. Surgical Lights: a)Hanaulux 2004 IXL cupola; b)Hanaulux 2005 I cupola; c)Hanaulux 2005 IXL cupola; d)Hanaulux 2004-2005 TV Spring Arm; e)XTEN DF cupola; f)XTEN LED Video DF cupola; g)XTEN LED DF cupola. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 7, 2009. Volume in Commerce: 940 units. Reason: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. FDA recalls #Z-0182/0188-2010. FDA Enforcement Report, 02/17/10.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Defibrillator/ Monitor: HeartStart MRx/MRxE. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 21, 2009. Volume in Commerce: 1,523 units. Reason: Incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed of that a low battery conditions exists prior to discontinuance from AC or DC power. FDA recall #Z-0003-2010. FDA Enforcement Report, 02/17/10.

STERIS CORP., Mentor, Ohio: Manufacturer: Drager Medical AG & Co. KGAA, Luebeck, Germany. Surgical Lights: Harmony LL 500/700, vertical spring-loaded arm. Class II. Firm initiated recall ongoing. Firm notified users by letter dated September 11, 2009. Volume in Commerce: 388 units. Reason: Four reported international cases received where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 broke as a result of a crack that developed over time. The Steris Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light. FDA recall #Z-0414-2010. FDA Enforcement Report, 02/17/10.