Agency classClass IIOur severity:High FDA (Devices)·Z-2488-2018·Announced 2018-07-25

Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

Cardinal Health 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. The hazard involves a mechanical defect (continuous suction) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves with Pulse Wave Cassette, Ref ASC1220. The recall involves specific lot numbers: 41718, 41770, 41768, 41769, 81702, and 81708. A total of 63,020 valves were distributed.

The recall is being issued because the suction valve may not close properly, which could cause continuous suction. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution was made to 34 U.S. states and the District of Columbia, as well as to government and military facilities. Foreign distribution included Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom. Users should check their inventory for the affected lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product: Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical / Anesthesia
Hazard: mechanical-defect
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 (6)

Lot numbers 41718
41770
41768
41769
81702
and 81708.

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 →

Same manufacturer · Cardinal Health 200, LLC

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