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Recall Observatory FDA recall evidence

Device 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.

Z-1754-2018

March 29, 2018

Class II

Product summary

Firm
Cook Inc.
Event
Event 79789
Status
Terminated
Classification
Class II
Quantity
304
Official record key
device-enforcement:Z-1754-2018

Official wording

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.

Code information: Lots 7844043, 7898128, 7940347, NS7904210

Distribution pattern: Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.