Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration
Cook Inc. is recalling 6,345 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (fluid leakage or air aspiration) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Cook Inc. is recalling 6,345 units of the Connecting Tube - Female to Male Luer Lock, model HPCT8.8-120-M-FM. The device is intended to serve as a conduit between a fluid reservoir and a vascular catheter in patients, and may be used during angiographic procedures to connect a radiographic contrast power injector to a vascular catheter, for arterial pressure monitoring, and for fluid infusion.
The recall is being issued because the cap-adapter assembly of the device may potentially not be adequately tightened. This defect could possibly lead to fluid leakage from the connecting tube or air aspiration into the tube.
The affected units were distributed to accounts in seven U.S. states: Alabama, California, Georgia, Nebraska, Nevada, New York, and Texas. International distribution occurred in Japan, Korea, and Taiwan. The recall covers specific lot numbers listed in the agency's official documentation. Users should stop using the affected devices and contact Cook Inc. for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Cook Inc.
- Affected units
- 6,345
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots 7797164
- 7844038
- 7844039
- 7844040
- 7844041
- 7844042
- 7846434
- 7846435
- 7853869
- 7853870
- 7853871
- 7853872
- 7853873
- 7853874
- 7857491
- 7857492
- 7857493
- 7857494
- 7857495
- 7857496
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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