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The FDA issued a nationwide alert for preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush and distributed by Rowlett, Texas-based Pinnacle Medical Supply because the products have not received proper clearance from the agency and may be contaminated.
Johnson & Johnson (J&J) announced the withdrawal of 300 Cypher stents from the U.S. market last week after an internal audit of manufacturing records revealed that six of the devices did not have sufficient polymer coating.
Roche Diagnostics announced a nationwide voluntary recall for its CARDIAC Reader system due to the potential that the testing instrument could start the measuring process before the user applies the sample.
Respiratory device manufacturer Pulmonetic Systems has issued a voluntary recall of 1,129 medical ventilator cable adaptors distributed between Nov. 2 and Nov. 8.