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 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
- 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
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.
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