FDA designates recall of central venous access, catheter kits as class I
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The FDA announced that Teleflex and Arrow International LLC are recalling both the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter Kit.
The FDA has identified this recall as class I, the most serious type of recall.
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According to the FDA notification, the reason for the recall is the risk of a cross-lumen leak “caused by inadequate connections between the top and bottom housings of the Micro Clave Clear Connectors included in the kits.”
The reason for the recall is the devices may reportedly cause bleeding, fluid leakage, delayed treatment, infection, air embolism, death or other serious injuries in patients treated with these device, though no injuries or deaths related to this issue have been reported by Teleflex and Arrow International.
According to the device use portion of the recall notification, The Arrow MAC Two-Lumen Central Venous Access Kit is intended to permit short-term venous access for fewer than 30 days and catheter introduction to the central circulation, while the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter Kit is intended to provide short-term protection against catheter-related bloodstream infections.
Teleflex and Arrow International sent customers an Urgent Medical Device Recall letter on October 27, 2022, that recommended customers stop use and distribution of the affected products and return all affected products to Teleflex for a refund, according to the FDA.
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