Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to packaging integrity (creased seals) with no reported injuries or illnesses, fitting the criteria for a low-risk packaging-only problem.
Plain-English summary
Teleflex Medical is recalling Aquapak 640 SW, 650 mL w/040 Adaptor, French, respiratory gas humidifier adaptors. The recall is due to a potential defect where the seals of the adaptor packaging may be creased, which could potentially affect packaging integrity.
The affected product is identified by Product Code 006-40F and includes lot numbers 020126, 046126, 062126, 064126, 080126, 092126, 107126, 108126, and 115126. A total of 7,758,650 units were distributed nationwide in the United States and in Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, the Philippines, Singapore, Thailand, and Zambia.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 7,758,650
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 (9)
- Product Code: 006-40F
- Lot numbers: 020126
- 046126
- 062126
- 064126
- 080126
- 092126
- 107126
- 108126 & 115126.
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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