Agency classClass IIOur severity:High FDA (Devices)·Z-1752-2018·Announced 2018-05-16

Cook Inc. Recalls Connecting Tubes Due to Potential Fluid 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 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 220 units of the Connecting Tube - Female to Male Luer Lock (model HPCT8.8-60-M-FM-BNS). The recall is due to a potential defect where the cap-adapter assembly of the device may not be adequately tightened.

This defect could possibly lead to fluid leakage from the connecting tube or air aspiration into the tube. The device is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient, often used during angiographic procedures to connect a radiographic contrast power injector to a vascular catheter, for arterial pressure monitoring, and for fluid infusion.

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 specific lot codes associated with this recall are NS7881928 and NS7898133.

The recalled product

Product: Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS 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…
Manufacturer: Cook Inc.
Category: Medical Device — Vascular Catheter Accessories
Hazard: fluid-leakage
air-aspiration
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 (2)

NS7881928
NS7898133

Distribution

Distributed in 7 states:

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.

See all 6 products in this recall →

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Same hazard · fluid leakage