FDA Issues Class I Recall of Surgical Staplers

A Class I recall is issued by the FDA when a drug or medical device  poses a threat of death or serious injury to patients.

Johnson & Johnson’s Ethicon Endo-Surgery unit recalled more than 157,000 of the surgical stapler devices and accessories used in the surgical treatment of prolapse and hemorrhoids.

The staplers were recalled due to the difficulty of firing the device, which may result in an incomplete firing stroke of the stapler and incomplete staple formation. The problem can cause severe pain, rectal wall damage, bleeding, sphincter dysfunction, sepsis, and occlusion of the rectal canal, reports the FDA.

The inability of these staplers to complete the firing stroke can also lead to poor staple formation causing separation of the rectal wall staple line along with bleeding.

The devices under recall are the Proximate PPH hemorrhoidal circular stapler and accessories, the Proximate HCS hemorrhoidal circular stapler and accessories, and the Transtar circular stapler procedure set, according to the FDA. The lots affected by the recall were manufactured and distributed from April 2011 to July 2012.

Granuflo News/Litigation for October 2012

Fresenius is facing yet anotherGranuFlo wrongful death lawsuit, this one filed in the U.S. District Court for the Southern District of Georgia. The lawsuit was filed by Waddell Bishop, on behalf of his mother, Frances Carol Bishop. She died of a severe cardiovascular event in September 2010, after she was given GranuFlo during dialysis treatment.

The U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte earlier this year, after the products were linked to hundreds of deaths. Most of the deaths were caused by heart attacks, sudden cardiac arrest, cardiopulmonary arrest, or congestive heart failure during dialysis treatments.

In the complaint, which was filed on September 14, the plaintiff alleges that “neither the product label, packaging, instructions, nor the packages containing the product, provided adequate instructions and/or warnings regarding the use of GranuFlo and/or NaturaLyte.” Furthermore, the lawsuit alleges that if Fresenius had provided adequate instructions or warnings, the plaintiff and her doctors never would have used the product.

Fresenius is the global leader in dialysis treatment and products, and they manufactureGranuFlo and NaturaLyte. The products are intended to be added to a patient’s blood during dialysis treatment (when the blood is removed, cleaned, and returned to the patient’s body). Dialysis naturally disrupts the balance of acid in the bloodstream, so doctors have to add products to the blood to balance the acidity before returning it to the patient. GranuFlo and NaturaLyte both contain chemicals that the patient’s liver rapidly converts to bicarbonate. If a healthcare professional does not adjust the dosage to compensate for this, the patient can easily suffer a life-threatening bicarbonate overdose, cardiovascular event, and death.

 

FDA recalls another CareFusion infusion pump

U.S. health regulators announced a recall of CareFusion’s Alaris pump module Model 8100, saying a potential keypad malfunction in the infusion pump could cause serious injury or death.

The U.S. Food and Drug Administration said the affected pump modules, used for delivering a variety of fluids, drugs and blood products to patients, were manufactured between October 2011 and February 2012.

The FDA classified the action as a Class I recall on its website, meaning that the defective units could cause serious harm to a patient’s health.

Read more: http://www.foxnews.com/health/2012/08/23/fda-recalls-another-carefusion-infusion-pump/#ixzz24qoamjlh

FDA Warns Again on Painkiller Supplement – Reumofan Plus

The FDA has issued a new warning against a Mexican “natural” dietary supplement marketed for pain relief due to unlabeled and potentially harmful drug ingredients.

Ongoing lab analysis of the supplements found that Reumofan Plus and Reumofan Plus Premium contain at least three unlabeled drug ingredients, including:

• Dexamethasone: a corticosteroid that can cause withdrawal syndrome if discontinued after long periods of use or high doses
• Diclofenac sodium: a nonsteroidal anti-inflammatory drug (NSAID) that can increase risk of serious cardiovascular and gastrointestinal events
• Methocarbamol: a muscle relaxant that can cause sedation, dizziness, hypotension, and impaired mental and physical abilities

 

The agency issued an initial warning against the products in June, 2012, due to adverse event reports that included incidents of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. Since that warning was issued, the FDA has received reports of severe bleeding and withdrawal syndrome, the agency said in a statement issued Tuesday.

 

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/34323

Zest Garden Recalls Wilson & Fisher Bistro Sets Due to Fall Hazard

News from the CPSC:

 

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of product: Wilson & Fisher White Cast Bistro Table and Chairs Set

Units: About 22,500

Retailer: Big Lots, of Columbus, Ohio

Importer: Zest Garden, of Ontario, Calif.

Hazard: The chairs can break during normal use, posing a fall hazard to consumers.

Incidents/Injuries: Zest Garden has received five reports of chairs breaking, including three reports of injuries.

Description: This recall involves three-piece patio sets sold in a white, cut-out rose pattern. The set consists of a table and two chairs made of cast iron and aluminum. The table is about 26 inches high and measures about 24 inches in diameter. Each chair is about 33 inches high with an oval-shaped seat that measures about 19 inches long and about 16 inches wide. The item number is XG-1015-23. The product measurements, the item number and “Wilson & Fisher White Cast Bistro Set” and “Made in China” are printed on labels located on the product’s packaging.

Sold exclusively at: Big Lots stores nationwide from November 2011 to May 2012 for about $100.

Manufactured in: China

Remedy: Consumers should immediately stop using the set and return it to any Big Lots store for a full refund.

Consumer Contact: For more information, contact Zest Garden at (800) 893-3006 between 9 a.m. and 5 p.m. PT, Monday through Friday, or send an e-mail toinfo@zestgarden.com, or visit the firm’s website at www.biglots.com

Pure Hothouse Foods Inc. : Recall of Fresh Cut Grilling Trays Because of Possible Health Risk

Pure Hothouse Foods Inc.  is recalling a total of 1402 cases and 8,412 individually distributed units of fresh cut grilling trays, as listed below, with the Sell by dates of August 11th, 2012 through August 26, 2012 because they contain whole or sliced mushrooms which may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life-threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.

The voluntary recalled products were produced and distributed from Pure Hothouse Foods Inc. in Leamington, Ontario, Canada to retailers in the following states: Michigan, Ohio, Indiana, Illinois, and Kentucky.

This voluntary recall notification is being issued due to finding Listeria monocytogenes in finished product that contained mushrooms. Pure Hothouse Foods Inc. is coordinating closely with regulatory officials.

No illnesses have been reported in association with this voluntary recall.

Pure Hothouse Foods Inc. customer service representatives have already contacted all customers impacted and are in the process of confirming that the recalled products are not in the stream of commerce. Consumers with questions may contact Pure Hothouse Foods Inc. directly at 1-866-326-8444 M-F 8am-5pm. (Eastern Standard Time)

Product Description	Use by Date	UPC Code
Meijer Brand “Grillers Mushroom with Rosemary”	August 11th – August 26th 2012	7-08820-85464-2
Meijer Brand “Grillers Steak Topper”	August 11th – August 26th 2012	7-08820-85468-0
Meijer Brand “Grillers Asparagus Blend”	August 11th – August 26th 2012	7-08820-85353-9

Only the specific products identified in the list above are included in this precautionary voluntary recall. Retailers should check their inventories and store shelves to confirm that none of the product is present or available for purchase by consumers or in warehouse inventories.

Synthes recalls certain lots of bone putty

SSUE: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

BACKGROUND: Hemostatic Bone Putty stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The affected models and lot numbers can be found in the FDA Recall Notice.

RECOMMENDATION: On July 5, 2012, Synthes issued a Medical Device Recall letter requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the Hemostatic Bone Putty.

If a facility had the affected product in stock, they were asked to call 1-800-479-6329 to obtain a Return Authorization Number, complete the verification form and return both the form and identified product to Synthes.

FDA Recalls All Lab’s Sterile Eye Products

The FDA has announced a recall of all sterile ophthalmologic preparations shipped from Franck’s Compounding Lab since November 2011 because of the possibility of a fungal eye infection following use.

The recall, originally initiated on March 19, 2012, first applied only to Brilliant Blue G, an ophthalmologic dye manufactured by the lab for use during surgical procedures.

Since that time, the recall has been expanded to include all preparations labeled sterile from the company following 33 cases of fungal eye infection in seven states after administration of Brilliant Blue G or products that contain triamcinolone from the compounding lab.

 

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/32934

Hospira recalls opioid drug cartridges

Hospira has recalled one lot of pre-filled cartridges containing the pain drug hydromorphone because the glass cartridges could contain too much medicine.

The company, which has been pressured by some product-quality issues, said there have been two reported complaints of a single “Carpuject” cartridge containing more than the amount of drug on the product’s label.

There have been no reports of adverse events related to this issue for this product lot, Hospira said, but overdoses on opioid pain drugs such as hydromorphone can pose life-threatening consequences.

 

http://www.marketwatch.com/story/hospira-recalls-opioid-drug-cartridges-2012-05-14

Wine Goblet Recalled

Enesco, LLC announced today that it is voluntarily recalling the ONIM “Any Wine Will Do” ceramic wine goblets, SKU # 4026171. Enesco is recalling the “Any Wine Will Do” wine goblets because, through its internal compliance and independent laboratory product testing program, it became aware that the wine goblets may exceed the Food and Drug Administration’s (“FDA”) guidance levels for leachable lead and cadmium. Enesco sold approximately 300 of the “Any Wine Will Do” wine goblets to retail stores in AR, CA, CO, FL, HI, IA, IL, IN, KS, KY, MD, MO, MI, MS, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SD, TX, VA, VT, WA and WI.

 

No illness related to this product has been reported. The recall only applies to this item and no other ONIM products are affected.

http://www.enewspf.com/latest-news/recalls/32500-enesco-voluntarily-recalls-any-wine-will-do-ceramic-wine-goblet.html