OxySure Model 615 Oxygen Cartridges Recalled for Flow Rate Defect
Oxysure Systems is recalling 1,005 Model 615 oxygen cartridges because they do not meet FDA flow rate standards.
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 that fails to meet safety standards for oxygen delivery, posing a risk of harm to users, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Oxysure Systems, Inc. is recalling 1,005 units of OxySure Model 615 disposable replacement cartridges for portable oxygen generators. The recall covers lots 61-65, which were distributed nationwide in the US as well as in Chile, Trinidad, and China.
The recalled cartridges are being recalled because their flow rate does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes. This defect means the devices may not deliver the required oxygen flow rate.
Consumers who have these specific cartridges should stop using them and contact Oxysure Systems, Inc. for instructions on how to return the product.
The recalled product
- Product
- OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
- Manufacturer
- Oxysure Systems, Inc.
- Category
- Medical Device — Oxygen Therapy
- Hazard
- Affected units
- 1,005
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)
- lots 61-65
Distribution
Distributed nationwide across the United States.
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