Teleflex Aquapak SW/EAU Sterile Respiratory Gas Humidifier Adaptor Packaging Recall
Teleflex Medical is recalling Aquapak SW/EAU Sterile 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 the hazard is a potential packaging integrity issue (creased seals) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is recalling Aquapak SW/EAU Sterile, 650 mL w/Adaptor 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 affected product codes are 006-40C, with lot numbers 029126, 036126, 065126, 071126, 076126, and 091126.
The recall was initiated because the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers should stop using the affected units and contact Teleflex Medical for further instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Aquapak SW/EAU Sterile, 650 mL w/Adaptor, 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 (6)
- Product Code: 006-40C
- Lot numbers: 029126
- 036126
- 065126
- 071126
- 076126 & 091126.
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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