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Recalls 1610 articles

Maquet recalls heart pump due to design issue

Maquet Datascope Corp., is recalling more than 2,800 CARDIOSAVE Hybrid Intra-aortic Balloon Pumps (IABPs) distributed nationwide due to a design defect that can lead to pump malfunction, which could result in serious and potentially fatal health consequences to patients. The recall is listed as a Class I, which is the most serious type of recall. Use of these devices may cause serious injuries or death. CARDIOSAVE Hybrid Intra-aortic Balloon Pumps (IABPs) are cardiac-assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure. Marquet Datascope is recalling the ... Read More

Salmonella Outbreak Linked To Fresh Melon Products

At least 60 people eight states have been sickened by Salmonella linked to melon products made and distributed by Caito Foods of Indianapolis, Indiana, spurring a recall of fresh cut melon and fruit salads, federal health officials announced. The U.S. Centers for Disease Control and Prevention (CDC) said that the outbreak of Salmonella illnesses stems from fresh cut watermelon, honeydew melon, cantaloupe, and fruit medley mixtures containing any of these melon products. Caito Foods and others distributed the affected melon products to Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina and Ohio. People infected by the melon products, which are ... Read More

Hospira recalls opioid antidote

Hospira Inc., a Pfizer company, is recalling two lots of the opioid overdose reversal agent Naloxone Hydrochloride injection because there may be bits of particulate matter embedded and loose on the Carpuject Single-use cartridge syringe plunger. If the drug is administered to a patient, there is a chance the patient could experience a range of adverse events including local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. To date, Hospira has not received any reports of adverse events related to this issue. The recall affects lots 72680LL and 76510LL of Naloxone Hydrochloride ... Read More

Resuscitator bags recalled due to defect

SunMed Holdings LLC is recalling 18,808 units of STAT-Check and Medline resuscitator bags due to a defect that could render the device unable to deliver air to the patient, which could result in a delay in treatment and life-threatening health consequence. There have been no injuries related to this issue, to date. STAT-Check and Medline resuscitator bags are hand-held devices commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately. In the resuscitator bags affected by the recall, the patient port retaining ring may not fully seat, which may allow the patient port ... Read More

MedTronic heart device recalled due to electrical error

Medtronic is recalling more than 200,000 HeartWare Ventricular Assist Devices (HVAD systems) due to an electrical issue that could cause the device to disconnect from its electrical source, causing the pump to stop. This issue could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death. This recall is classified as a Class I recall, which is the most serious type of recall. Class I recalls are issued when use of a medical device may cause serious adverse events or death. The recall affects certain models ... Read More

Bits of glass in nasal spray prompts recall

Apotex Corp. is recalling an allergy nasal spray after a customer complained about finding bits of glass in a bottle of the medication. The glass particles could block the actuator and impact the pump. But even more disturbing is the risk that some users may inadvertently spray the glass up their noses. “Mechanical irritation cannot be ruled out,” the company said in a news release. “Local trauma to the nasal mucosa might occur with use of the defective product.” To date, Apotex Corp. has not received any repots of adverse events related to this issue. The recall affects lot # ... Read More

Birth control pills recalled due to packaging error

Allergan is recalling physician sample packs of the birth control pills Taytulla after receiving a physician report that four of the placebo capsules were placed out of order with the first four days of therapy having four non-hormonal capsules instead of active ones. The reversing of the order may not be apparent to either new users or previous users, increasing the likelihood of taking the capsules out of order. This error could put the user at risk for unintended pregnancy. Taytulla is a contraceptive used by women to prevent pregnancy. The recall involves lot number 5620706 of Taytulla softgel capsules ... Read More

Ice cream, sherbets recalled, may contain metal bits

H-E-B is recalling certain flavors and container sizes of EconoMax and Hill Country Fare ice cream and Creamy Creations sherbet because they may contain bits of metal from a broken part found in processing equipment during routine maintenance. The affected ice creams and sherbets were distributed to H-E-B stores in Texas and Mexico. To date, no injuries have been reported due to this incident. H-E-B says it has already removed all related products from its store shelves and intends to have a new shipment to replace them as soon as possible. The recall involves 4-quart, 4.5-quart, quart, and 56-ounce cartons ... Read More

Shave cream, acne products recalled due to potential contamination

Topical shave creams, acne products and pain gels manufactured by Shadow Holdings are being recalled because they may be contaminated with bacteria that could lead to serious infections in people with compromised immune systems. To date, no reports of adverse events have been associated with use of these products. Affected products include all lots within expiration date of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit. Herb-X Solutions X-Jow Pain Gel is an external analgesic, and is packaged in 4 oz. and 8 oz. bottles. ... Read More

Medtronic recalls revascularization device due to defect

Medtronic is recalling the MindFrame Capture LP revascularization device used to during procedures to treat strokes because the delivery wire may break or separate during use, leaving the clot retriever inside the patient’s bloodstream. This, or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death. The MindFrame Capture LP revascularization device used to restore blood flow or remove blood clots within in a blood vessel in the brain during an acute ischemic stoke in patients ineligible for or who fail intravenous plasminogen activator (IV ... Read More