Agency classClass IIOur severity:High FDA (Devices)·Z-1098-2015·Announced 2015-02-18

Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because 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 involves a medical device with a potential foreign material hazard (black particles) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Teleflex Medical is recalling the Aquapak 340 SW, 340 ML W/040B Adaptor, BRI. 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. The affected product is identified by Product Code 003-40B and Lot numbers 394137, 429137, 542147, 674147, 396137, and 312137. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

The product was distributed nationwide in the U.S. and in 25 other countries, including Australia, Canada, China, Germany, and Japan. Healthcare facilities and consumers should check their inventory for the specific lot numbers and product codes listed. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor.

The recalled product

Product: AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI 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
Category: Medical Device — Respiratory Therapy
Hazard: foreign-material
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 (6)

Product Code: 003-40B
Lot numbers: 394137
429137
542147
674147
396137 & 312137.

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.

See all 15 products in this recall →

Same manufacturer · Teleflex Medical

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Same hazard · foreign material