The Recall Desk
HighFDA (Devices)·Z-2494-2018·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 is classified as FDA Class II, and the hazard involves a risk of harm (continuous suction) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves (Ref ASU1220) because the suction valve may not close properly. This defect could result in continuous suction during use.

A total of 63,020 valves were distributed to healthcare facilities in 34 U.S. states, the District of Columbia, and government and military facilities. The product was also distributed to Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom. The affected lot numbers are 71725, 81743, 91722, and 101723.

Healthcare providers should stop using the affected valves and contact Cardinal Health for further instructions. Consumers should not use these products and should contact their healthcare provider if they have questions.

The recalled product

Product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Instruments
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 (4)

  • Lot numbers 71725
  • 81743
  • 91722
  • and 101723.

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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