Agency classClass IIOur severity:High FDA (Devices)·Z-2487-2018·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, and the hazard involves a functional defect in a medical device that could lead to continuous suction, posing a risk of harm without reported fatalities or severe injuries.

Plain-English summary

Cardinal Health 200, LLC is recalling the Hydroline Trumpet Valve with Pulse Wave Cassette, Ref ASC1201. The recall involves 63,020 units distributed to various U.S. states, government and military facilities, and several foreign countries.

The recall was initiated because the suction valve may not close properly, which could result in continuous suction. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

Healthcare providers and facilities should stop using the affected valves and contact Cardinal Health for instructions on return or replacement. Patients who have had these valves used should consult their healthcare provider if they experience issues related to suction.

The recalled product

Product: Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Instruments
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 (16)

Lot numbers 11742
41742
41746
41752
41751
41761
41762
41753
41763
41765
41754
41756
41759
41755
41757
and 41758.

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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Same hazard · malfunction