Z-1756-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- March 29, 2018
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6345
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
Code Information
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