The Recall Desk
HighFDA (Devices)·Z-2491-2018·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.

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 functional defect in a medical device that could lead to continuous suction, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves, a sterile, single-use medical device used for suction. The recall involves 63,020 units distributed across 34 U.S. 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.

The recall was initiated because the suction valve may not close properly, which could cause continuous suction. This defect poses a risk to patients who rely on the device for intermittent suction control.

Healthcare providers and facilities should stop using the affected valves and contact Cardinal Health 200, LLC for instructions on return or replacement. Consumers should not use the product if they have it in their possession.

The recalled product

Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, 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 (20)

  • Lot numbers 31712
  • 31711
  • 31713
  • 31714
  • 31764
  • 31765
  • 41711
  • 41713
  • 41715
  • 41724
  • 41737
  • 41714
  • 41721
  • 41722
  • 41723
  • 41727
  • 41726
  • 41725
  • 41719
  • 41731

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

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