Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall covers 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 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 involves a medical device with a risk of harm (foreign material in sterile water packages) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Teleflex Medical is recalling the Aquapak 640 SW, 650ML W/040 Adaptor, International. This product is a humidifier adaptor accessory that allows the connection of 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 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. The specific product code is 400640, and the recall includes a wide range of lot numbers listed in the agency's official documentation.
Healthcare facilities and consumers should stop using the affected Aquapak 640 SW humidifier adaptors immediately. Users should check their inventory for the specific product code and lot numbers to identify affected units. Teleflex Medical is the recalling firm responsible for this action.
The recalled product
- Product
- AQUAPAK 640 SW, 650ML 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: 400640
- Lot numbers: 002146
- 018136
- 039136
- 022136
- 143136
- 109136
- 134136
- 053146
- 180136
- 069146
- 080136
- 169136
- 048146
- 086136
- 006146
- 175136
- 063146
- 037146
- 055146
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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