Cook Inc. Recalls Connecting Tubes Due to Potential Leakage
Cook Inc. is recalling 220 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 is classified as FDA Class II. The hazard involves potential fluid leakage or air aspiration in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Cook Inc. is recalling 220 units of the Connecting Tube - Female to Male Luer Lock, model HPCT8.8-60-M-FM. The recall involves lots 7853883, 7871665, and 7940332. These devices are 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 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 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. The source text does not specify the actions consumers or healthcare providers should take.
The recalled product
- Product
- Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-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
- 220
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 (1)
- lots 7853883 7871665 7940332
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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