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 12 other countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a packaging integrity issue with no reported illnesses or injuries, which aligns with the rubric for moderate severity voluntary precautionary recalls.
Plain-English summary
Teleflex Medical is voluntarily recalling Aquapak 640 SW, 650 mL w/040 Adaptor respiratory gas humidifier adaptors. The recall is due to a potential defect where the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity.
The affected product is identified by Product Code 006-40J and includes lot numbers 028126, 035126, 045126, 063126, 098126, 105126, and 106126. A total of 7,758,650 units are involved in this recall. The products were distributed nationwide in the United States as well as in Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, the Philippines, Singapore, Thailand, and Zambia.
Healthcare facilities and distributors should stop using the affected units and contact Teleflex Medical for instructions on how to return or dispose of the product. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, 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 (7)
- Product Code: 006-40J
- Lot numbers: 028126
- 035126
- 045126
- 063126
- 098126
- 105126 & 106126.
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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