Teleflex Aquapak 340 SW Respiratory Gas Humidifier Adaptor Packaging Recall
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
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: The recall is classified as FDA Class II and involves a packaging integrity issue (creased seals) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Teleflex Medical is recalling Aquapak 340 SW, 340 mL w/040 Adaptor, French, respiratory gas humidifier adaptors. The recall involves 7,758,650 units 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 recall was initiated because the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity. The agency has classified this as a Class II recall.
Healthcare facilities and distributors should stop using the affected products and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- Aquapak 340 SW, 340, 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 (20)
- Product Code: 003-40F
- Lot numbers: 046127
- 049127
- 052127
- 053127
- 055127
- 056127
- 058127
- 059127
- 061127
- 062127
- 065127
- 066127
- 068127
- 069127
- 071127
- 072127
- 074127
- 211127
- 213127
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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