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Medical device warnings & news
DePuy Orthopaedics/JNJ hip replacement recall
Those individuals who have had a hip replacement manufactured by DePuy Orthopaedics, a division of Johnson & Johnson, after 2005 may need a replacement of this defective product. Most significant affects include increased metal levels in blood, which are not often tested but can lead to metallic poisoning, other side effects include damage to person's body from metal on metal of defective hip, bone staining, necrosis, swelling, tissue damage, nerve damage and muscle damage.
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
Nov. 5, 2008 -- The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.
These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.
The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.
Chattem Issues URGENT Voluntary Nationwide Recall of Icy Hot® Heat Therapy™ Products
February 8, 2008 -- Chattem, Inc. announced today that it is initiating a voluntary Nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz. Aspercreme® product. This recall is being conducted to the consumer level.
Chattem is recalling these products because it has received some consumer reports of first, second and third degree burns as well as skin irritation resulting from consumer use or possible misuse of these products.
NOTE: if products have been removed from their holding cartons the recalled products are packaged in a red colored plastic pouch which states Icy Hot Heat Therapy and either Back or Arm/Neck and Leg.
Single consumer use "samples" of Icy Hot Heat Therapy- Arm, Neck and Leg were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as "Icy Hot Heat Therapy Air Activated Heat," with their own internal labeling.
Consumers who have the Icy Hot Heat Therapy products under recall should immediately stop using the products, discard them, and/or return them to Chattem, Inc.
FDA Warns Public of Contaminated Syringes
AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes
Jan. 25, 2008 The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.
Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should also let their health care providers know that they have been exposed to syringes recalled by FDA.
The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.
Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.
B. Braun's Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes
AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label
January 18, 2008 -- B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.
Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted.
CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
December 20, 2007 --- Cardinal Health today issued the following update to the company’s worldwide voluntary recall for its Alaris® Pump module:
On Nov. 5, 2007, Cardinal Health notified customers of a voluntary recall for all Alaris® Pump modules, model 8100 (formerly known as Medley™ Pump module), shipped prior to Sept. 27, 2007.
The reason for this recall is that the units may contain misassembled occluder springs (bent, broken, nested or missing). These conditions have occurred due to misassembly during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion.
The company became aware of the issue from a review of customer complaints and service data. Cardinal Health has received one report of an injury and two reports of patient deaths associated with the use of this device. The deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this issue.
Nov. 16, 1007: Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Implantable Ventricular Assist Devices (IVADs) Driver, serial numbers 488 and higher (located on the label of the sterile package and on the driveline’s Y-connector), manufactured and distributed from October 1, 2004 through October 22, 2007. The device is a mechanical air-driven (pneumatic) pump that helps a person's heart that is too weak to pump blood through the body. The current instructions for use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline that could result in not enough blood flow to and from the heart. This recall does not affect implanted IVADs. Physicians should contact their patients if any Thoratec IVAD was placed in the external position and patients should contact their physicians with any questions.
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