Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]
Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers
[UPDATED 08/25/2009] FDA notified healthcare professionals of a Class 1 recall of these models of the Stabilet infant warmer because these out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire. On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. Class I 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 injury or death.
[Posted 07/22/2009] Draeger Medical and FDA notified healthcare professionals that it recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire. Draeger agrees with the recommendation to remove the referenced Stabilet models from service immediately. Immediate actions required include:
- Locate and identify the devices listed in this notice.
- Remove the referenced devices from service as soon as possible.
- Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.
- If an infant is currently receiving therapy from one of the referenced devices, consider the risk of moving the patient before changing to an alternative mode of therapy.
A recall notification is being sent out to all known current users and is available in the Draeger website at www.draeger.com/Stabilet. Health care professionals and consumers should report serious adverse events (side effects) or product quality problems with the use of this product to Draeger Medical Systems Inc. or to the FDA’s MedWatch Adverse Event reporting Program (www.fda.gov/medwatch/report.htm)
August 25, 2009
Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]
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Michael Jackson costumes center of lawsuit from English wig maker
Michael Jackson costumes center of lawsuit from English wig makerMichael Jackson costumes center of lawsuit from English wig maker
Tuesday, August 25th 2009, 4:00 AM
Anderson/News
Michael Jackson's resemblance is clear in 'Plastic Man Wig with Glasses,' being sold by Rubie's Costume Co.
A famed English wigmaker is flipping its top over a Queens company's plans to hawk Michael Jackson costumes.
Century-old Smiffy's sued Rubie's Costume Co. in Manhattan Federal Court on Monday, claiming it has the worldwide rights to sell King of Pop getups for years to come.
Smiffy's, which was founded as a maker of powdered wigs for stuffy English judges, has successfully branched out into selling Jackson costumes.
Among its best sellers are the single-gloved "Billie Jean" costume and the "Bad" costume with a flowing black wig.
The venerable wigmaker says it owns the rights to the costumes and says Rubie's already has cost it more than $250,000 in orders by making phony marketing pitches to potential customers.
Not so, says Rubie's.
The Richmond Hill company says the suit is totally "Off the Wall" and claims it obtained the Jackson costume rights from a California company.
"Rubie's Officially is the Worldwide Licensee for Michael Jackson Costumes and Accessories," Rubie's Vice President Howard Beige wrote in an e-mail sent out last week, according to the lawsuit.
Rubie's already has the rights to market Elvis Presley costumes, and predicts Jackson will rival the swivel-hipped rocker in costume sales.
"He's going to be an iconic figure, like Elvis and Marilyn Monroe who will be a perennial seller," Beige said.