Atos Medical Recalls Provox Life Night HME Devices Due to Insertion Risk
Atos Medical AB is recalling Provox Life Night HME devices because they may be incorrectly inserted, potentially blocking the patient's stoma.
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 (airway occlusion) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Atos Medical AB is recalling 225 boxes of 30 Provox Life Night HME devices (Catalogue Number 8262). These are single-use heat and moisture exchangers intended for patients breathing through a tracheostoma. The affected lot numbers are 2012158 and 2012124.
The recall was initiated because the devices may be incorrectly inserted sideways or forcefully through the adhesive coupling. This error can potentially occlude or block the stoma, which is the opening in the neck used for breathing.
The devices were distributed nationwide in the United States, specifically in the states of Illinois, Connecticut, Virginia, New Mexico, New York, South Carolina, New Jersey, Oklahoma, Minnesota, Michigan, North Carolina, Ohio, Arizona, Wisconsin, California, Pennsylvania, and Idaho. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
- Manufacturer
- Atos Medical AB
- Category
- Medical Device — Respiratory
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 (1)
- Lot Numbers: 2012158 and 2012124
Distribution
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