Z-1754-2018 Class II Terminated
FDA device recall Z-1754-2018 was initiated by Cook Inc. on Mar 29, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 304.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 29, 2018
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 304
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.
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.
Distribution Pattern
Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
Code Information
Lots 7844043, 7898128, 7940347, NS7904210
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1754-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026