Class 2 Device Recall Connecting Tube Female to Male Luer Lock

• Date Initiated by Firm: March 29, 2018
• Date Posted: May 09, 2018
• Recall Status: Terminated on April 09, 2019
• Recall Number: Z-1751-2018
• Recall Event ID: 79789
• Product Classification: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
• Product: Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-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.
• Code Information: lots 7853883 7871665 7940332
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 800-457-4500
• Manufacturer 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.
• FDA Determined Cause: Equipment maintenance
• Action: 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.
• Quantity in Commerce: 220
• Distribution: Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.