Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration
Cook Inc. is recalling 886 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Cook Inc. is recalling 886 units of the Connecting Tube - Female to Male Luer Lock (model HPCT8.8-30-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 radiographic contrast power injectors to vascular catheters, for arterial pressure monitoring, and for fluid infusion.
The recall was initiated 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 lots are 7828771, 7846437, 7863752, 7881930, 7886974, and 7886975. The products were distributed to accounts in seven U.S. states (AL, CA, GA, NE, NV, NY, and TX) and internationally to Japan, Korea, and Taiwan. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-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
- 886
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 (6)
- Lots 7828771
- 7846437
- 7863752
- 7881930
- 7886974
- 7886975
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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