FDA Device recall Z-1755-2018
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-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, HPCT8.8-100-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-1755-2018 |
| 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, HPCT8.8-100-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 NS7835000, NS7835001, NS7846433, NS7853877, NS7853880, NS7866660, NS7875342, NS7898129, NS7898130, NS7898131, NS7928009, NS7928014, NS7940349 |
|---|
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-1755-2018%22
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