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Clinipad Sterile Products Recalled

The FDA announced that Clinipad Corp. of Rocky Hill, Conn., is voluntarily recalling antiseptic sterile skin preparations because of a potential for bacter...

WASHINGTON, March 10, 2000 --
The Food and Drug Administration today announced that Clinipad Corp. of Rocky Hill, Conn., is voluntarily recalling antiseptic sterile skin preparations because of a potential for bacterial contamination.

The reason for the recall is that the company has confirmed bacterial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa and Stenotrophomonas maltophilia (recalled in December 1999), and therefore cannot assure the sterility of products labeled and sold as sterile.

These organisms can cause skin, wound, or other infections that may be serious or life-threatening in some cases.

The nationwide recall of the Clinipad sterile-products line includes Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic Products, as well as Sterile Cliniguard Protective Dressing Labeled as "sterile," manufactured since Jan. 1, 1997.

The products (swabsticks, prep pads, towelettes, ointments and pouches, as well as protective dressings) are distributed under the names: Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical Corp., and Rauscher. They are sold separately or packaged in various institutional kits and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies and are used to control and prevent infection.

In addition to other medical uses, these products are used to prepare the skin prior to the collection of blood or plasma donations. Although there have been no known instances of blood contamination traced to the recalled products, clinicians should remain alert to this possibility.

Contamination of blood collections with bacteria from the skin contributes to rare bacterial infections from transfusions. Serious bacterial infections occur in approximately 1 out of 50,000 to 1 out of 500,000 transfusions, depending on the exact blood product administered. Recent data from CDC have shown no increase in bacterial contamination of transfused blood products over a two-year period.

All lots of the sterile products line involved in the recall have a lot number beginning with 7, 8, 9, or 0, and are labeled as "sterile" on the unit of use packaging, or "sterile unless opened or damaged." The lot numbers are also found on the shipping carton or its label.

Clinipad Corp. is sending recall notices to 3,000 customers and 100 kit manufacturers. These customers are being advised to examine stocks and remove the recalled products, including products in kits, and to promptly destroy them. Health professionals and consumers who have the product with the involved lot numbers should destroy the product.

To assist blood collection centers in developing alternative skin preparations, the Food and Drug Administration, Center for Biologics Evaluation and Research, has posted information on its Websites at www.fda.gov/cber/infosheets.htm and www.fda.gov/cber/recalls.htm. The sites identify alternative products and procedures that can be used at donor centers.

Health professionals and consumers who have these products can obtain more information about the recall from FDA's MedWatch Website. Also, consumers with questions may contact the Clinipad Corporation at 860-571-0100.

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Skeet Shoot Game Recalled

Skeet Shoot Game Recalled...

WASHINGTON, April 5, 2000 -- Toymax is recalling approximately 435,000 Arcadia Electronic Skeet Shoot games to replace the game cartridges.

Skeet ShootThe cartridges can be defective, and can cause the projector to overheat, melt and smoke, presenting a risk of burns to consumers.

Toymax has received 100 reports of projectors overheating, melting and smoking. A consumer reportedly suffering a minor burn injury on the hand, and damages included two scorched carpets and one scorched bedspread.

Toy and discount department stores nationwide, including Toys R Us, Sam's Club, K·B Toys and Costco, sold these games from October 1998 through March 2000 for about $65.

Consumers should stop using these games immediately and remove the game cartridge from the console. To receive a free replacement game cartridge or for more information, contact Toymax at (800) 477-6215 anytime. Consumers also can go to the company web site at www.toymax.com. Consumers should not return these games or cartridges to stores.

New and replacement game cartridges are orange. All the Arcadia Electronic Skeet Shoot games cartridges that are not orange should be replaced.

The Arcadia Electronic Skeet Shoot game sets are an indoor image projecting game systems that include Duck Shoot and Deer Hunter games. The game sets includes a toy pump-action rifle with a simulated laser scope and realistic shooting sounds when fired.

The Duck Shoot game has a gray rifle and projector. The Deer Hunter game has a camouflage rifle and projector. "ARCADIA ELECTRONIC SKEET SHOOT" is written on a label on the projector. Writing on the bottom of the projector includes "1998 TOYMAX," "PATENT PENDING" and "MADE IN CHINA." Meteor Attack and Fighter Attack game cartridges, which are used with the Arcadia Electronic Skeet Shoot games, are sold separately. The Meteor Attack cartridge is silver and the Fighter Attack cartridge is black.

 

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Futons Recalled

Futons Recalled because of flammability danger...


WASHINGTON, April 4, 2000 -- D.C. In cooperation with the U.S. Consumer Product Safety Commission (CPSC), The Standard Mattress Co., of Hartford, Conn., is voluntarily recalling approximately 47,000 futons.

Some of these futons may fail cigarette ignition resistance tests, in violation of the federal Flammable Fabrics Act, because the boric acid flame retardant inside the futons may not have been evenly disbursed. This could result in burn injuries, should one of these futons catch fire.

CPSC and The Standard Mattress Co. are not aware of any fires or injuries involving these futons. This recall is being conducted to prevent the possibility of injuries.

Furniture and futon stores nationwide sold the futons from May 1998 through October 1998 for $140 to $250.

Consumers who purchased one of these futons during this period should immediately call The Standard Mattress Co. toll-free at (888) 512-6169 anytime to obtain a free replacement futon. Consumers should not return the futons to the stores where they purchased them. Replacements are available only by calling the company.

The futons being recalled were sold between May 1998 and October 1998 with model numbers 605, 608, 611, and 613, sold under the brand names of Gold Bond, IKEA, and Verlo. The model number and brand name are located on the permanently sewn-in label. The futons come in varied sizes, most of which are full size. Other sizes include king/chair, queen and twin. All are covered in a cotton/polyester fabric in a natural (off-white) color.

 

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BISSELL Vacuum Cleaners Recalled

BISSELL Vacuum Cleaners Recalled...


WASHINGTON, April 4, 2000 -- - BISSELL Homecare is recalling about 207,000 "PowerClean" and "PureAir" upright vacuum cleaners. The power cord insulation can tear where the cord attaches to the vacuum, exposing bare wires, posing a risk of shock and burns.

Bissell VacuumsBISSELL is aware of 54 reports of such indients., including one report of a consumer suffering a burn injury on her hand.

Major discount, appliance and department stores sold these vacuum cleaners nationwide from July 1998 through March 2000 for between $89 and $159.

Consumers should stop using these vacuum cleaners immediately, and contact BISSELL to arrange for a free repair through BISSELL's authorized service network. Vacuums cannot be repaired by the retailers. For the location of the nearest authorized service center or for more information, contact BISSELL toll-free at (888) 445-6688 between 8 a.m. and 7:30 p.m. ET Monday through Friday or visit their web site.

The recall includes one model of the PowerClean vacuum and three models of the PureAir vacuum cleaners. The PowerClean vacuum has model number 3540-1 and is black. The PureAir vacuum has model number 3540-2 and is blue. The PureAir Deluxe vacuum has model number 3541, and is purple. The PureAir Platinum vacuum has model number 3541-P, and is purple. The model number is located on a label on the back of the vacuum.

These vacuums have date codes from 98176000 through 99254999, located in the bottom right-hand corner of the label. The recalled vacuums do not have a 3-inch plastic flex relief where the power cord enters the vacuum handle.

 

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