Cook Inc. Recalls Connecting Tubes Due to Potential Leakage
Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing 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 no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Cook Inc. is recalling 304 units of the Connecting Tube - Female to Male Luer Lock, model HPCT8.8-80-M-FM. The device is intended to serve as a conduit between a fluid reservoir and a vascular catheter in patients, often used during angiographic procedures to connect radiographic contrast power injectors to vascular catheters, 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 lead to fluid leakage from the connecting tube or air aspiration into the tube.
The affected lots are 7844043, 7898128, 7940347, and NS7904210. The products 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. Users should stop using the affected devices and contact Cook Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- Cook Inc.
- Affected units
- 304
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 (4)
- Lots 7844043
- 7898128
- 7940347
- NS7904210
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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