Devices & Diagnostics

FDA classifies recall of mislabeled multi-lumen catheter Class I

The U.S. Food and Drug Administration on Tuesday classified Arrow International’s recall of a mislabeled catheter as Class I, the most serious of all recalls that typically have a high likelihood of serious injury or death. Arrow International, a subsidiary of Teleflex, recalled its Arrowg+ard multi-lumen catheter in May because of a major mislabeling that […]

By Arundhati Parmar on August 01, 2012 2:17 pm

The U.S. Food and Drug Administration on Tuesday classified Arrow International’s recall of a mislabeled catheter as Class I, the most serious of all recalls that typically have a high likelihood of serious injury or death.

Arrow International, a subsidiary of Teleflex, recalled its Arrowg+ard multi-lumen catheter in May because of a major mislabeling that leads people to believe that the product does not contain medication when in fact it contains chlorhexidine and silver sulfadiazine. Further, information on  chlorhexidine contraindication is missing from the label.

FDA said the product could seriously harm a patient who is allergic to chlorhexidine and silver sulfadiazine. The products were sold between Dec. 9, 2010 through Feb. 29, 2012

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