Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-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. |
| Quantity | 220 |
| Distribution | Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan. |
| Initiated | 2018-03-29 |
| Classified | 2018-05-08 |
| Terminated | 2019-04-09 |
| Recall number | Z-1751-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-1751-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79789/
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