Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-1754-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-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.

Product Classification:

Class II

Date Initiated: March 29, 2018

Date Posted: May 16, 2018

Recall Number: Z-1754-2018

Event ID: 79789

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.

Status: Terminated

Product Quantity: 304

Code Information:

Lots 7844043, 7898128, 7940347, NS7904210

Distribution Pattern:

Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated