Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material
Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is the presence of foreign material (black particles) in the packaging, which is a quality control issue without reported adverse health consequences.
Plain-English summary
Teleflex Medical is recalling the Aquapak 340 SW, 340ML W/040 Adaptor, International. This product is a medical device accessory used to connect sterile water or sterile saline to a humidifier circuit for inhalation therapy. The recall is being conducted because the packages may contain foreign material, specifically black particles.
The recall involves 15,779,607 units. The affected products were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, China, Germany, and Japan. The recall covers specific lot numbers, including 001147, 061137, and 313147, among others.
Healthcare facilities and distributors should stop using the affected Aquapak 340 SW humidifier adaptors. Users should check their inventory against the provided lot numbers and product code 400340. If the product is found, it should be quarantined and returned to Teleflex Medical according to their instructions.
The recalled product
- Product
- AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. 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 therapy gases. Only the 040 Humidifier adaptor…
- 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 (20)
- Product Code: 400340
- Lot numbers: 001147
- 061137
- 313147
- 059137
- 010147
- 293137
- 038147
- 225137
- 558137
- 362137
- 202147
- 425137
- 301147
- 263137
- 366137
- 076147
- 316137
- 424137
- 012147
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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