The Recall Desk
HighFDA (Devices)·Z-2495-2018·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.

What this means for you

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 risk-of-harm product where the defect could cause continuous suction, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves, Reference ASU1221. The product is a single-use, sterile medical device packaged in boxes of one, with 12 boxes per case.

The recall is being issued because the suction valve may not close properly, which could cause continuous suction. A total of 63,020 valves were distributed to various states in the United States, the District of Columbia, government and military facilities, and foreign countries including Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom. The affected lot numbers are 21719 and 41738.

Healthcare providers and consumers should stop using the affected valves and contact Cardinal Health for further instructions or a replacement.

The recalled product

Product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Suction Valves
Hazard
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 (1)

  • Lot numbers 21719 and 41738.

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 →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · malfunction

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