Device 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.
Z-1755-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 554
- Official record key
device-enforcement:Z-1755-2018
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 NS7835000, NS7835001, NS7846433, NS7853877, NS7853880, NS7866660, NS7875342, NS7898129, NS7898130, NS7898131, NS7928009, NS7928014, NS7940349
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
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.