FDA Device recall Z-1756-2018
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid… by Cook, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1756-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-29 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | AL, CA, GA, NE, NV, NY, TX |
Product
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-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
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.
Identifiers
| code_info | Lots 7797164, 7844038, 7844039, 7844040, 7844041, 7844042, 7846434, 7846435, 7853869, 7853870, 7853871, 7853872, 785387…Lots 7797164, 7844038, 7844039, 7844040, 7844041, 7844042, 7846434, 7846435, 7853869, 7853870, 7853871, 7853872, 7853873, 7853874, 7857491, 7857492, 7857493, 7857494, 7857495, 7857496, 7857497, 7857498, 7857499, 7857500, 7863742, 7863744, 7863745, 7863747, 7863748, 7863749, 7863750, 7863751, 7871644, 7871645, 7871646, 7871647, 7881937, 7881938, 7881939, 7881940, 7881941, 7881942, 7888498, 7888505, 7888506, 7888507, 7917423, 7917424, 7917425, 7917426, 7917434, 7925136, 7925137, 7925138, 7925139, 7925140, 7940326, 7940327, 7940328, 7940345, 7940346, 7949048, NS7835002, NS7875343, NS7881929, NS7888468, NS7928016, NS7940350 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1756-2018%22
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