ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns
ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.
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. Per the rubric, Class II recalls without explicit reports of hospitalization or death are typically scored as High (3), representing a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E. The recall was initiated by the firm on May 10, 2017, and was classified by the FDA as Class II. The affected lot numbers are 100163, 100464, 101671, 102011, 102397, 102787, 102856, 103850, and 104901.
The source text does not specify the exact reason for the recall or the specific hazard associated with the device. The recall status is listed as Terminated, with a termination date of August 27, 2021. The initial firm notification was sent via letter.
The affected products were distributed in the United States (CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA, and Puerto Rico) and internationally in Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam. Consumers should check their oxygen masks for the listed lot numbers and contact ConvaTec or their healthcare provider for instructions on replacement or return.
The recalled product
- Product
- Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Oxygen Therapy
- Hazard
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 (9)
- Lot Number 100163
- 100464
- 101671
- 102011
- 102397
- 102787
- 102856
- 103850
- 104901
Distribution
Part of a larger recall action
This product is one of 18 recalled by ConvaTec, Inc 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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