medical Class II Updated 2018-05-16

Cook Inc. recalls Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM

Recalled Product

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

Hazard / Issue

Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.

Issued by

FDA

Affected States: AL, CA, GA, NE, NV, NY, TX

Lot/Code Info: Lots 7797164, 7844038, 7844039, 7844040, 7844041, 7844042, 7846434, 7846435, 7853869, 7853870, 7853871, 7853872, 7853873, 7853874, 7857491, 7857492, 7857493, 7857494, 7857495, 7857496, 7857497, 7857498, 7857499, 7857500, 7863742, 7863744, 7863745, 7863747, 7863748, 7863749, 7863750, 7863751, 7871644, 7871645, 7871646, 7871647, 7881937, 7881938, 7881939, 7881940, 7881941, 7881942, 7888498, 7888505, 7888506, 7888507, 7917423, 7917424, 7917425, 7917426, 7917434, 7925136, 7925137, 7925138, 7925139, 7925140, 7940326, 7940327, 7940328, 7940345, 7940346, 7949048, NS7835002, NS7875343, NS7881929, NS7888468, NS7928016, NS7940350

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