Teleflex Medical Recalls Aquapak SW/EAU Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak SW/EAU respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
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 Low severity because the issue is a packaging integrity concern (creased seals) without reported injuries or illnesses, fitting the rubric for packaging-only problems.
Plain-English summary
Teleflex Medical is recalling Aquapak SW/EAU, Sterile, 340 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 recall was initiated because the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity. The affected product code is 003-40C, and the specific lot numbers are 109127, 155127, 157127, 174127, 195127, 222127, 277127, 335127, 337127, 384127, 422127, 425127, 497127, and 500127.
Healthcare providers and consumers should check their inventory for these specific lot numbers and contact Teleflex Medical for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- Aquapak SW/EAU, Sterile, 340 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 (14)
- Product Code: 003-40C
- Lot numbers: 109127
- 155127
- 157127
- 174127
- 195127
- 222127
- 277127
- 335127
- 337127
- 384127
- 422127
- 425127
- 497127 & 500127.
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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