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Latest Medical Device News

Alli 60 mg capsules (120 count refill kit): Counterfeit Product - UPDATE [01/23/2010] Previous alert updated with information on laboratory analysis of sibutramine levels in counterfeit product - Product sold over the internet contains controlled substance sibutramine.
Cordis CROSSOVER Sheath Introducer - Recall - [UPDATED 12/23/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use.
Edwards Lifesciences Aquarius Hemodialysis System: Recall - Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals - Recall - Selected varieties recalled due to packaging defect that could cause possible bacterial contamination.
Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall - Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall - Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted.
McNeil Consumer Healthcare Over-The-Counter Products: Recall - December 2009 recall expanded to multiple products.
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review - Contraindication to use in patients with history of cardiovascular disease.
MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall - Dietary supplements recalled due to undeclared steroids in products, posing risk of acute liver injury.
Nipro GlucoPro Insulin Syringes: Recall - Needles may become detached and remain in the skin.
Nzu, Traditional Remedy for Morning Sickness - Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
Rapamune (sirolimus): Drug Monitoring Recommendations - Switching between assays for the same patient can produce differing results that may be clinically significant.
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical - Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Thermoflect Blankets and product line - Recall - FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots - [UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
Tysabri (Natalizumab): Update of Healthcare Professional Information - Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment - Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension - Risk information added to Warnings/Precautions section and data summary provided
Zyprexa (olanzapine): Use in Adolescents - Clinicians should consider the potential long-term risks when prescribing to adolescents.
ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall - Device may crack near the radiopaque marker band, potentially resulting in serious patient injury.

Radiation Problems Prompt Push Towards New Measures

February 5th, 2010 meg

The leading professional organization dedicated to radiation oncology has called for enhanced safety measures in administering medical radiation.

The American Society for Radiation Oncology is asking for the nation’s first central database for the reporting of errors involving linear accelerators and CT scanners.

The group, also known as Astro, has issued a six-point plan that it said would improve safety and quality and reduce the chances of medical errors.

Even though Astro says serious radiation accidents are rare, it will work toward a stronger accreditation program and expanded training.

In addition, the group will press for federal legislation to require national standards for radiation therapy treatment teams.

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