Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a cond

FDA device recall Z-1755-2018 · posted 2018-05-09 · Terminated

Recall details

Recalling firm

Cook Inc.

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

DTL

Quantity affected

554

Distribution

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

Date initiated

2018-03-29

Date posted

2018-05-09

Date terminated

2019-04-09

Location

Bloomington, IN