Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black particles.
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 involves a medical device with a risk of harm (foreign material) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Teleflex Medical is recalling Aquapak SW/EAU Sterile, 650 ml with adaptor products. The recall involves 15,779,607 units of the 040 Humidifier adaptor pack, which is an accessory used to connect sterile water or saline to a humidifier circuit for inhalation therapy.
The recall was initiated because the packages may contain foreign material, specifically black particles. The affected product code is 006-40C, and the recall covers specific lot numbers including 040136, 062136, 029136, 013146, 083146, 178136, 048136, 171136, 074136, 104136, 020146, 060136, 039146, 035133, and 087136.
The affected units were distributed worldwide, including in the United States and countries such as Australia, Canada, China, Germany, and Japan. Users should check their product codes and lot numbers against the recall list and contact Teleflex Medical for further instructions.
The recalled product
- Product
- AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. 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 (15)
- Product Code: 006-40C
- Lot numbers: 040136
- 062136
- 029136
- 013146
- 083146
- 178136
- 048136
- 171136
- 074136
- 104136
- 020146
- 060136
- 039146
- 035136 & 087136.
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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