Teleflex Recalls Hudson RCI Humidifier Adaptors Due to Foreign Material
Teleflex Medical is recalling specific Hudson RCI Humidifier Adaptors because the packages may contain black particles. The recall affects units distributed worldwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential foreign material (black particles) in the packaging. No specific injuries or illnesses are reported in the source text, and the risk is considered moderate rather than severe.
Plain-English summary
Teleflex Medical is recalling specific units of the Hudson RCI Humidifier Adaptor, product code 000-40. The recall involves 15,779,607 total units, specifically those packaged with a water bottle and bearing lot numbers BE08, BG05, BG08, BM18, CB11, or CB17. The product is an accessory used to connect sterile water or saline to a humidifier circuit for inhalation therapy.
The recall was initiated because the packages may contain foreign material, specifically black particles. The affected units were distributed nationwide in the United States and in numerous countries worldwide, including Australia, Canada, China, Germany, and Japan.
Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed above. If the product matches the recalled description, it should be removed from use and returned to Teleflex Medical or the original supplier for further instructions.
The recalled product
- Product
- Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 15,779,607
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 (5)
- Product Code: 000-40
- Lot numbers: BE08
- BG05 BG08
- BM18
- CB11 & CB17.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Teleflex Medical 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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