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Latest Medical Device News

• 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP - Recall of one lot due to possible incorrect bar code for 5% Dextrose Injection, USP. The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication.
• Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences - Recall issued because the 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.
• Greenline-D MacIntosh No. 3 Laryngoscope Blades - Class 1 recall due to potential for piece of blade to break off during procedure.
• Healon D Ophthalmic Viscosurgical Device - Recall of one lot of the product because some of the tested OVD syringes had endotoxin levels above the required limit.
• Hydromorphone HCl 2 mg Tablets - Nationwide recall of a single lot due to potential for oversized tablets.
• Innohep (tinzaparin sodium injection) - [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency
• October 2008 Safety Labeling Changes - Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
• Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) - Reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products.
• Stryker Custom Cranial Implant Kits - Class 1 recall because sterility cannot be assured.
• Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae - Worldwide recall involving 21 lot codes, due to reports of difficulty retracting the introducer from the cannula.
• Weight Loss Pills - Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.

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