Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors Due to Foreign Material
Teleflex Medical is recalling Aquapak 640 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 no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Teleflex Medical is recalling the Aquapak 640 SW, 650ML W/040 Adaptor, FREN. 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 involves 15,779,607 units. The affected product code is 006-40J, and the specific lot numbers are 028146, 075136, 083136, 103136, 111136, 113136, 146136, 029146, 007146, 114136, 034146, 068136, 126136, 033146, and 112136. Only the 040 Humidifier adaptor packaged with the water bottle is affected.
The product was distributed nationwide in the United States and in numerous countries including Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay, and Zambia. Healthcare facilities and consumers should stop using the affected lots and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. 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 pac
- 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 (15)
- Product Code: 006-40J
- Lot numbers: 028146
- 075136
- 083136
- 103136
- 111136
- 113136
- 146136
- 029146
- 007146
- 114136
- 034146
- 068136
- 126136
- 033146 & 112136.
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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