—#163456

Product

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.

FDA product code: DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lots 7844043, 7898128, 7940347, NS7904210

Why it was recalled

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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

On March 29, 2018, the recalling firm mailed recall notifications to affected customers. Customers were informed that the affected devices may have been manufactured with equipment that was out of calibration, which could result in the cap-adapter assembly of the device not being adequately tightened. Customers were advised of potential adverse events. Customers were instructed to 1) Examine inventory immediately to determine if they have affected product, and quarantine affected product. Immediately cease all distribution and use of the recalled lots. 2) Return the affected product to the recalling firm with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3) Complete the Acknowledgement and Receipt Form even if the customer does not have affected products on hand. 4) Immediately report adverse events to the recalling firm. Customers with further questions were directed to contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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

Timeline

Recall initiated: 2018-03-29
Posted by FDA: 2018-05-09
Terminated: 2019-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.