Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black foreign particles.
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 is classified as FDA Class II, and the presence of foreign material in a sterile medical device presents a risk of harm, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling approximately 15.8 million units of Aquapak SW/EAU Sterile, 340 ml with Adaptor. This medical device accessory is used to connect sterile water or saline to a humidifier circuit for inhalation therapy. The recall is being conducted because the packages may contain foreign material, specifically black particles.
The affected product is identified by Product Code 003-40C and specific lot numbers, including 124147, 615137, and 144137. The recall covers units distributed worldwide, including the United States and numerous international markets such as Australia, Canada, Germany, and Japan.
Healthcare facilities and consumers should stop using the affected Aquapak sterile water humidifier adaptors. Users should contact Teleflex Medical for further instructions on how to return or dispose of the product.
The recalled product
- Product
- AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR 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: 003-40C
- Lot numbers: 124147
- 615137
- 144137
- 536137
- 553137
- 187137
- 099147
- 307147
- 230147
- 414137
- 280147
- 296137
- 193137
- 346147
- 021147
- 504137
- 451137
- 249137
- 592137
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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