Agency classClass IIOur severity:High FDA (Devices)·Z-2486-2018·Announced 2018-07-25

Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

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, and the hazard involves a risk of harm (continuous suction) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Cardinal Health 200, LLC is recalling specific lots of Hydroline Trumpet Valves with Pulse Wave Cassette. The affected products are sterile, single-use medical devices used for suctioning. The recall involves lot numbers 41742, 41739, 41740, and 41741.

The recall was initiated because the suction valve may not close properly. This defect could result in continuous suction, which poses a risk to patient safety during medical procedures. A total of 63,020 valves were distributed to various states in the United States, the District of Columbia, and several foreign countries, including Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom. Government and military distribution was also reported.

Healthcare facilities and consumers who have these specific lot numbers should stop using the product immediately. Users should contact Cardinal Health 200, LLC for instructions on how to return the product or obtain a replacement.

The recalled product

Product: Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Suction Valves
Hazard: malfunction
continuous-suction
Affected units: 63,020

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)

Lot numbers 41742
41739
41740
and 41741.

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 11 recalled by Cardinal Health 200, LLC 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 11 products in this recall →

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