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Latest Consumer News

• Class I Medical Device Recall: Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD) - Reason for Recall: Some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome (TASS) in patients following surgery.
• Class I Medical Device Recall: Integra NeuroSciences, Gravity Compensating Accessory - Reason for Recall: These devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.
• Class I Medical Device Recall: Stryker Leibinger USA., Stryker Custom Cranial Implant Kits - Reason for Recall: The company is recalling these products because sterility cannot be assured.
• Class I Medical Device Recall: Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades - A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure.
• Consumer Information on: E-LUMINEXX Vascular Stent - P080007 - The E-LUMINEXX Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries).

Archive for October, 2007

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