Agency classClass IIOur severity:High FDA (Devices)·Z-1097-2015·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 is classified as FDA Class II. The hazard involves foreign material (black particles) in a medical device used for inhalation therapy, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex Medical is recalling the Aquapak 340 SW, 340 ML W/404 Adaptor. This medical device accessory is used to connect sterile water or sterile saline to a humidifier circuit for inhalation therapy. The recall is being issued because the packages may contain foreign material, specifically black particles.

Approximately 15,779,607 units are affected by this recall. The products were distributed nationwide in the United States and in numerous international markets, including Australia, Canada, China, Germany, Japan, and the United Kingdom. The recall covers specific lot numbers listed in the official FDA notice.

Healthcare facilities and consumers should stop using the affected Aquapak 340 SW humidifier adaptors immediately. Users should contact Teleflex Medical for instructions on how to return the product or obtain a replacement. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: AQUAPAK 340 SW, 340 ML W/404 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
Category: Medical Device — Respiratory Therapy
Hazard: foreign-material
contamination
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: 003-40
Lot numbers: 062137
060137
038137
039137
054137
088137
445147
052137
051137
380137
055137
167137
176137
271147
356147
585137
260147
625137
131137

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