Agency classClass IIOur severity:High FDA (Devices)·Z-1101-2015·Announced 2015-02-18

Teleflex Medical Recalls Aquapak 340 Humidifier Adaptors Due to Foreign Material

Teleflex Medical is recalling Aquapak 340 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, 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 recalling the Aquapak 340 SW, 340, ML W/040, Adaptor, Japa. 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 the 040 Humidifier adaptor packaged with the water bottle. The distribution was worldwide, including the United States and numerous international markets such as Australia, Canada, China, Germany, Japan, and the United Kingdom.

Healthcare providers and consumers should stop using the affected Aquapak 340 Humidifier Adaptors immediately. Users should check their inventory for the specific product code 003-40J and the listed lot numbers to identify affected units. Teleflex Medical is the recalling firm responsible for managing this Class II recall.

The recalled product

Product: AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. 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 (20)

Product Code: 003-40J
Lot numbers: 149147
017147
165147
337137
400137
240137
492137
015147
163147
151147
118147
613137
130137
398137
180137
244137
406137
169147
212137

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