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AHA - American Hospital Association

12/01/2021 | News release | Distributed by Public on 12/01/2021 15:47

FDA classifies device recall as serious due to potential for harm

Teleflex has recalled a percutaneous thrombolytic device kit due to reports that a component could detach from the device and embolize. The Food and Drug Administration has classified this as a Class 1 recall, the most serious type, due to the potential for serious adverse health consequences or death. The company said it has received seven complaints about the issue, but no reports of long-term patient complications. It advises health care providers to immediately stop using and return all affected product, and identify all patients currently exposed to it. Providers also may report adverse reactions or quality problems using the product to the FDA's MedWatch program.