Lids of the Pressure Injectable Catheter Kits incorrectly state the cardiovascular devices are not coated with chlorhexidine, a disinfectant, while the banner cards on the side of packages are correct.
Teleflex and Arrow International advised consumers to stop using the products, which could lead to serious adverse events in people who are allergic to chlorhexidine, the FDA said Nov. 6.
No injuries or deaths have been reported.
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