Z-1754-2018Class II

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

Name: Z-1754-2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM
Creator: Cook Inc.
Published: 2018-03-29
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-03-29 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of 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... on 2018-03-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1754-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-29
Posted: 2018-05-09
Terminated: 2019-04-09
Recalling firm: Cook Incorporated
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.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root 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: 304
Distribution: Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
Product codes and lots: Lots 7844043, 7898128, 7940347, NS7904210

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1754-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1751-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1752-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1753-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1754-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1755-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1756-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08

Product code DTL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)