Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling 7,758,650 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 specific hazard is a packaging integrity issue (creased seals) with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.
Plain-English summary
Teleflex Medical is recalling 7,758,650 units of the Adaptor, 040 Hum, International, a respiratory gas humidifier adaptor. The recall is being conducted because the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity.
The affected product is identified by Product Code 4000040 and Lot number AG14. These 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.
Consumers and healthcare facilities should stop using the affected adaptors and contact Teleflex Medical for further instructions on how to proceed with the recall.
The recalled product
- Product
- Adaptor, 040 Hum, International, 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 (2)
- Product Code: 4000040
- Lot number: AG14.
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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