Medical Device recall alerts and consumer safety news updated hourly http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices Tue, 16 Mar 2010 23:08:23 +0100 http://www.recallowl.com/images/rss.gif http://www.recallowl.com The feed is managed/created by RecallOwl.com (http://www.recallowl.com). http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Teleflex+Incorporated+Announces+Worldwide+Voluntary+Recall+of+Arrow+Select+IV+Tubing+Sets%2C+Accessories%2C+and+Certain+Embolectomy+Catheters - March 12, 2010 - Limerick, PA - Teleflex Incorporated provided an update today on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010. Testing revealed pin holes in some of the pouches in which the products are packaged,... Mon, 15 Mar 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/LifeScan+Recalls+Specific+Lots+of+Consumer+and+Professional+OneTouch%26%23174%3B+SureStep%26%23174%3B+Test+Strips+Due+To+Inaccurate -- MILPITAS, Calif., Feb. 24 /PRNewswire/ -- LifeScan, Inc. is conducting a voluntary recall in the United States 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. The eight lots of consumer OneTouch SureStep Test Strips being reca... Fri, 26 Feb 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/BD+Announces+Worldwide+Voluntary+Recall+ofBD+Q-Syte%26%238482%3B+Luer+Access+Devices+and+BD+Nexiva%26%238482%3B+Closed+IV+Catheter+Systems - Franklin Lakes, NJ (February 8, 2010) - BD (Becton, Dickinson and Company) (NYSE:BDX) has voluntarily executed a product recall of certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by let... Tue, 09 Feb 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Cardiac+Science+Notifies+AED+Customers+of+Voluntary+Medical+Device+Recall - February 3, 2010 - Bothell, WA - Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a 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. Th... Tue, 09 Feb 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Acacia%2C+Inc.+Announces+Worldwide+Voluntary+Recall+of+IV+Extension+Sets+with+BD+Q-Syte%26%238482%3B+Luer+Access+Device - Brea, CA (February 9, 2010) - Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company). Use of the affected BD Q-Syte™ Luer Access Device may cause an air embolism or leakage of blood and/or therapy, which may result in... Tue, 09 Feb 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/FDA+Announces+Class+I+Recall+of+Certain+Infusion+Set+Needles : Jan. 26, 2010 Media Inquiries: Peper Long, 301-796-4671, mailto:mary.long@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA Announces Class I Recall of Certain Infusion Set NeedlesHuber needles used in implanted ports to withdraw blood, inject medications, and other solutions The U.S. Food and Drug Administration to... Tue, 26 Jan 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Nipro+Medical+Corporation+Issues+a+Voluntary+Recall+of+All+GlucoPro+Insulin+Syringes ... Fri, 22 Jan 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Hettich+Centrifuges+Issues+a+North+America+and+Canada+Recall+of+Plastic+Hematocrit+Rotors - January 21, 2010 - Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the potential to break apart resulting in pieces of the rotor to be forcefully ejected through the plastic centrifuge housing. This may result in seriou... Fri, 22 Jan 2010 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Encompass+Group+Voluntarily+Recalls+Thermoflect+Product+Line - December 26, 2009 - McDonough, GA - Jea R. Gackowski, Encompass Group Corporate Compliance Officer announced today the company is voluntarily recalling the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. "We are voluntarily recalling the product line from use in the Magnetic Resonance (MR) environment," Gackowski said. "We are requesting that the Thermoflect blankets and other products... Mon, 28 Dec 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Stryker+Operating+Room+System+II+Surgical+Navigation+System+-+Recall Recall Class: Class I Date Recall Initiated:  October 26, 2009 Product:  Operating Room System II Surgical Navigation Systems Product Name Stryker Catalog Number Serial#/Lot# Range... Fri, 27 Nov 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Cardiovascular+Systems+Initiates+Voluntary+Recall+of+ViperSheathTM+Sheath+Introducer - November 16, 2009 - ST. PAUL, Minn. - Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheathTMSheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009. The ViperSheathTM Sheath Introducer is a product developed and manufactured by Thomas Medical ... Tue, 17 Nov 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Cardiovascular+Systems+ViperSheath+Sheath+Introducer Product: ViperSheath Sheath Introducer is manufactured by Thomas Medical Products, Inc. and is distributed by Cardiovascular Systems, Inc. (CSI). Lot RangesCatalog Numbers S28117 through S29174 VPR-ISH 5 X 85, VPR-ISH 6 X 85,... Tue, 17 Nov 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Cardiac+Science+Notifies+AED+Customers+of+Nationwide+Voluntary+Medical+Device+Correction Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the ... Sat, 14 Nov 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Synthes+USA%2C+Ti+Synex+II+Vertebral+Body+Replacement+-+Class+I+Recall On September 23, 2009, the company notified hospitals and sales consultants about this recall by mail. The company: identified the recalled product described the problem and potential health effects provided instructions to their customers to return all products in their inventory and all surgically removed devices for evaluation. notified and provided instructions to physicians and patients (through their physicians) ... Thu, 12 Nov 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Centurion+Medical+Products+-+Premie+Pack+and+Meconium+Pack+-+Recall Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient.... Wed, 04 Nov 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Cordis+Initiates+Nationwide+Recall+of+CROSSOVER%26%238482%3B+Sheath+Introducer - October 23, 2009 - BRIDGEWATER, NJ. - October 23, 2009 - Cordis Corporation announced today a nationwide voluntary recall of all lots of the CROSSOVER™ Sheath Introducer due to complaints about stretching or fracture of the sheath during use. The CROSSOVER™ Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant cathet... Fri, 30 Oct 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Qualitest+Pharmaceuticals+Issues+a+Voluntary+Nationwide+Recall+of+All+Accusure%26%23174%3B+Insulin+Syringes - October 27, 2009 - Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc... Tue, 27 Oct 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Unomedical+Issues+Worldwide+Recall+of+Certain+Manual+Pulmonary+Resuscitators - October 06, 2009 - McAllen, Texas - Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 - March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.un... Wed, 07 Oct 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Philips+Issues+Worldwide+Recall+of+Select+Heartstart+Fr2%2B+Automated+External+Defibrillators - September 28, 2009 - Seattle - Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured betw... Sat, 03 Oct 2009 07:00:00 +0100 http://www.recallowl.com/Drug+and+Medical+Recalls/Medical+Devices/Penumbra+Announces+Worldwide+Voluntary+Field+Removal+of+the+Original+Version+of+6F+Neuron+070+Delivery+Catheter - September 29, 2009 - ALAMEDA, CA - (BUSINESS WIRE)- Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of o... Wed, 30 Sep 2009 07:00:00 +0100