Institute of Good Manufacturing Practices India®

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Teleflex catheterization kit recall due to 10 injuries, 1 death

Teleflex is recalling about 335,000 catheterization kits in the U.S. following the Food and Drug Administration's announcement of an issue linked to 10 injuries and one death. The company urged customers to quarantine Arrow Quickflash Catheterization Kits in February due to increased resistance in the guidewire handle and chamber during use.

Teleflex issued an urgent field safety notice, alerting healthcare professionals to a potentially defective component in kits used for accessing a patient’s peripheral arterial circulation or other small vessels. The resistance in the guidewire could result in multiple arterial punctures during attempts to access vessels.

Despite receiving 194 complaints regarding resistance in the guidewire handle/chamber during use as of Jan. 31, Teleflex noted that none resulted in injury. The FDA disclosed that Teleflex reported 194 complaints, including 10 injuries and one death. This recall adds to a series of quality issues concerning Arrow products acquired by Teleflex in a $2 billion deal in 2007, including mislabeling regarding chlorhexidine presence and complaints about separations and leakage, both categorized as Class I events by the FDA.