Teleflex Medical Recalls Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling 7.7 million Humidifier Adaptors because creased packaging seals may affect integrity. The products were 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: The recall is classified as FDA Class II, but the hazard is limited to potential packaging integrity issues with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is recalling approximately 7,758,650 Humidifier Adaptors, 040 Shelf Pak, French. The recall was initiated because the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity. The affected products are identified by Product Code 000-40F and Lot numbers AA05 and AC01.
The recalled items 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. The FDA has classified this as a Class II recall.
Consumers and healthcare facilities should stop using the affected Humidifier Adaptors and contact Teleflex Medical for instructions on how to return or replace the products.
The recalled product
- Product
- Humidifier Adaptor, 040 Shelf Pak, 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 (2)
- Product Code: 000-40F
- Lot numbers: AA05 & AC01.
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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