Becton Dickinson & Co. is recalling millions of intravenous devices that may cause air embolism or other potentially lethal complications.

The recall involves BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were recalled were distributed in the United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America. A complete list of the REF and lot numbers included in this recall can be found here. (more…)

Medical device maker ev3 Endovascular, Inc. has recalled about 350 Trailblazer Support Catheters. Customers were notified of the recall in November, and all devices have been returned to the firm.

The Food & Drug Administration has deemed this action a Class I recall. Class I recalls are the agency’s most serious type of recall, and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death. (more…)

All lots of the ViperSheath Sheath Introducer have been recalled because of a breakage risk.  According to Cardiovascular Systems Inc.’s (CSI) recall notice, there have been three  reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. The ViperSheath Sheath Introducer is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device (more…)

A Class I recall has been issued for the Ti Synex II Vertebral Body Replacement device by Synthes USA.  The U.S. Food & Drug Administration (FDA) has directed that surgeons and hospitals in possession of the recalled devices stop implanting them immediately. Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon.

The FDA has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall. Class 1 recalls are the FDA’s  most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death. (more…)

Del Monte cantaloupes sold throughout throughout Northern California and Nevada are being recalled because of  potential Salmonella contamination.  According to Mercury News, the recalled Del Monte cantaloupes were sold at at Raley’s and at Raley’s subsidiaries: Nob Hill Foods and Food Source.

Salmonella is usually found in food contaminated with animal feces and is a group of bacteria that passes from the feces of people or animals to other people or animals, causing contamination when food is improperly stored or handled and when preparers do not wash their hands or sanitize implements involved in food storage. Salmonella is the most frequently reported cause of food-related outbreaks of stomach illness worldwide. Salmonella poisoning can lead to Reiter’s Syndrome, a difficult-to-treat reactive arthritis characterized by severe joint pain, irritation of the eyes, and painful urination. (more…)

Sun Med of Largo, FL has issued a Class I recall for its Greenline/D MacIntosh No. 3 Laryngoscope Blades.  The laryngoscope blades were recalled because a piece of the acrylic light tube that runs along the laryngoscope blade may break off during procedures. The Food & Drug Administration (FDA) issues Class I recalls when there is a reasonable probability that the use of a device will cause adverse health consequences or death.

According to the FDA recall notice, the blades are part of a medical device (laryngoscope) used to view the vocal cords and other structures when opening a patient’s airway.  The FDA said that Sun Med has sent a notice to their distributors requesting that the defective laryngoscope blades be returned.  Customers with questions may contact Sun Med at 1-727-530-7099. (more…)

The Vibrational Integrated Bio-photonic Energizer (VIBE device) and the Nebion HLX8 device – both unapproved medical devices – are subject to a Class I Recall. A Class I recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.  According to the FDA, the manufactures of  both devices claimed they treated conditions ranging from cancer to migraines. The agency  is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

According to the FDA, Nebion LLC of Los Angeles, Calif. recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval, the FDA said.  The recall followed a June 2008 FDA inspection of the company which revealed that Nebion had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation. (more…)

Advanced Medical Optics (AMO) has issued another recall of a contaminated product.  This time, the company is recalling its Healon D Ophthalmic Viscosurgical Device (OVD) after testing revealed endotoxin levels that were too high.

This is not the first time an AMO product has been recalled for contamination problems.  Between 2006 and 2007, AMO issued two such recalls some of its Complete MoisturePlus products.  In some cases, these recalled products caused serious eye infections, leading to permanent injury for some victims. (more…)

ReliOn Insulin Syringes used by diabetics have been recalled by Tyco Healthcare Group LP (Covidien) because of an overdose risk. During the packaging process, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin. The Food & Drug Administration (FDA) said the 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.

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.  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. (more…)

A health alert issued in June by Medtronic regarding problems with catheters used with its implantable intrathecal drug pumps has been deemed a Class I recall by the  Food & Drug Administration (FDA), the agency’s most serious type.  Medtronic says it has received 83 reports of infusion system difficulties worldwide that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump. In one case, a patient died from acute baclofen withdrawal related to complications from an improperly connected catheter.

Neither the June health alert  nor the FDA’s classification Friday called on patients to have devices removed, and hospitals and doctors are not being asked to return unused products.   However, patients who experience the catheter problems described in the recall will require a surgical procedure for correction, Medtronic said. (more…)