Teleflex Medical Recalls Aquapak 101 SW Humidifier Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak 101 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.
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 involves a medical device with a risk of harm (foreign material) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Teleflex Medical is recalling the Aquapak 101 SW, 190ML W/040 Adaptor, JAPA. This medical device accessory is 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 affects 15,779,607 units. The specific product code is 001-40J, and the affected lot numbers are 001139 and 003139. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Australia, Canada, China, Germany, Japan, and the United Kingdom. Consumers and healthcare facilities should stop using the affected products and contact Teleflex Medical for instructions on how to return them.
The recalled product
- Product
- AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA 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 pack
- 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 (2)
- Product Code: 001-40J
- Lot numbers: 001139 & 003139.
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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