Use: Automated peritoneal dialysis (PD) systems are prescription medical devices used to treat pediatric and adult patients with kidney failure.
In PD, a soft tube called a catheter is used to fill the abdomen with a cleansing liquid called dialysis solution. The walls of the abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from the blood into the dialysis solution. These wastes and fluid then leave the body when the dialysis solution is drained. Several fill – drain cycles are typically needed during a treatment. Automated PD systems, like the HomeChoice systems, can be programmed to deliver and remove several cycles of doctor-prescribed amounts of dialysis solution.
HomeChoice systems are used in conjunction with Baxter’s single use disposable tubing sets and bags of dialysis solutions.
The HomeChoice PRO model also has a small electronic data card, called a PRO card, which stores information from the nurse or doctor and automatically sets up the system for the patient.
Recalling Firm:
Baxter Healthcare Corporation
One Baxter Way
Deerfield, IL 60015
Reason for Recall: Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV can cause serious breathing and heart problems that can result in serious injury or death.
Public Contact: If you need assistance with your HomeChoice or HomeChoice PRO, call the Baxter Customer Service line, available 24 hours and day, 7 days a week at 1-800-553-6898.
FDA District: Chicago
FDA Comments:
Although Baxter is not removing the HomeChoice and HomeChoice PRO from the market, clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices.

IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.

Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended.

Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Patients and caregivers should watch for the potential signs of IIPV. If patients or caregivers notice any of the signs of IIPV, stop the device, initiate manual drain, and contact your doctor immediately. Please refer to the Baxter press release, for a list of signs and symptoms of IIPV and more specific instructions for what to do if symptoms appear.

Any adverse reactions experienced with the use of this product or quality problems should be reported to the Baxter Renal Division at 1-888-736-2543, prompt 3 (Corporate Product Surveillance), and the FDA’s MedWatch Program by phone at 1-800-FDA-l088.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

* Influend Cold and Cough, 24 Tablets, Product Code/ Lot # 800074
* Influend Severe Cold & Flu, 24 Tablets, Product Code/Lot# 800075
* Influend JR. Cold & Cough, 4 oz. bottle, Product Code/Lot# 800076
* Influend JR. Severe Cold & Flu, 4 oz. bottle, Product Code/Lot# 800077

While no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

ION Labs, Inc.
115th Ave. N.
Clearwater, Fl. 33760

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at the MedWatch website at www.fda.gov/medwatch

Consumers who have questions about the above recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT.

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms.

Increased Risk of Digoxin Toxicity

The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products. Lawyers for the company could not be reached for comment.

Expanded Recall to Retail Level Includes the Following Products:

Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)

Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)

Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)

Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)

Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)

Any retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

WHAT IS THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM?

The HeartMate II is a high-speed, axial flow, rotary blood pump. As an axial flow device, the  HeartMate II produces no pulsatile action. Weighing 12 ounces (about 375 grams) and measuring about 1.5 inches (4 cm) in diameter and 2.5 inches (6 cm) long, it is significantly smaller than other currently approved devices. As such, it may be suitable for a wider range of patients, including small adults and children.

The internal pump surfaces are a smooth, polished titanium. Within the pump is a rotor that contains a magnet. The rotor assembly is rotated  by the electromotive force generated by the motor. The rotor propels the blood from the inflow cannula out to the natural circulation. The pump speed can vary from 6,000 rpm to 15,000 rpm, providing blood flow of up to 10 liters per minute.

The pump can run in two operating modes: fixed speed and auto-speed. In fixed-speed mode, the device operates at a constant speed, which can be adjusted via the system monitor. In the auto-speed mode, the pump speed varies in response to different levels of patient or cardiac activity.

HEARTMATE II RECALLED

Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003.  Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients died.

CONTACT AN ATTORNEY NOW!

If you or someone you love were hurt by the HeartMate II Left Ventricular Assist System, contact our defective product attorneys for a free evaluation today!

Sold in the United States under the brand name Duragesic by PriCara and generically by Sandoz Inc., the recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009.

Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug’s packaging, it could cause a patient or caregiver to come into direct contact with this powerful “opioid” drug. This could result in difficulty breathing and a potentially fatal overdose.

Learn More: Yahoo News

Icy Hot Heat Therapy Air Activated Heat – Back
Icy Hot Heat Therapy Air Activated Heat – Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal – Arm, Neck, and Leg single consumer use “samples” on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream.

Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer.