Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because the packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of foreign material in a medical device used for inhalation therapy presents a risk of harm, even though specific injuries are not reported in the source text.
Plain-English summary
Teleflex Medical is voluntarily recalling the Aquapak 340 SW, 340 ML W/040 Adaptor, French. This medical device accessory is used to connect sterile water or sterile saline to a humidifier circuit for inhalation therapy. The recall is being conducted because the packages may contain foreign material, specifically black particles.
The recall involves 15,779,607 units of the product. The affected items were distributed nationwide in the United States and in numerous countries, including Australia, Canada, China, Germany, Japan, and the United Kingdom. The recall covers specific lot numbers, including 506147, 238137, and 288137, among others.
Healthcare providers and consumers should stop using the affected Aquapak 340 SW humidifier adaptors and contact Teleflex Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 15,779,607
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: 506147
- 238137
- 288137
- 298137
- 292147
- 062147
- 045147
- 066147
- 565137
- 393137
- 468137
- 242137
- 404137
- 462147
- 462137
- 511137
- 077147
- 360137
- 384137
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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