This is a list of recent Class I recalls. A Class I recall is the most serious type of FDA recall and involve situations in which there is a reasonable probability that use of the recalled product will cause adverse health effects or wrongful death.
List of 2010 FDA Medical Device Recalls (August-September)
09/21/10 Symbiq One and Two-Channel Infusers: There is potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. When unrestricted flow occurs, the “Check Flow Stop” alarm, which is designed to notify users of a free flow condition, may not function as intended and may not provide warning to users. Unrestricted flow of medication or other therapy may have life-threatening effects and may cause critical patient injury, especially in critically ill patients, patients with congestive heart failure and newborns.
09/08/10 AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter: The catheters may become separated during use in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.
08/26/10 Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles: FDA testing determined that the Huber-style needles in these products “cored” in 23 to 86 percent of tests.
08/23/10 Ikaria Holdings, INOMAX DS Drug Delivery System: The component within the pressure switch, that monitors when the drug supply should be replaced, may tear. Risks to the patient include possible interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system. The delay may cause a worsening of low blood oxygen level (hypoxemia), low blood pressure (hypotension) and/or an increase in blood pressure in the pulmonary arteries (pulmonary hypertension). Any of these conditions could lead to wrongful death.
08/13/10 St. Jude Medical 6 French Engage Introducer Devices: In some devices in the affected batches, a separation of the shaft (sheath) from the hub or a break in the hub assembly may occur. If either were to occur during use, a potentially life threatening bleeding could occur.
08/04/10 Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube: These products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that was previously recalled. The tubes may leak air, resulting in inadequate ventilation. Use of these products can result in serious injury, including death.
For more information about recalled medical devices, read:
2010 FDA Dangerous Medical Device Recalls: Part 1 - If You Were Injured By Any Of These Devices, You May Have a Kansas City Personal Injury Claim
2010 FDA Dangerous Medical Device Recalls: Part 2 - If You Were Injured By A Recalled Medical Device, You May Be Eligible For Compensation. Learn More.
2010 FDA Dangerous Medical Device Recalls: Part 3 - These Defective Medical Devices May Cause Serious Injury Or Death.
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