POM Medical Recalls Procedural Oxygen Masks Due to Defective Re-breather Bags
POM Medical LLC is recalling 5,610 procedural oxygen masks because the re-breather bag may not inflate or the oxygen line may pop off due to a clogged port.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes functional defects (bag not inflating, line popping off) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
POM Medical LLC is recalling 5,610 units of POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Masks. The affected products include POM Medical REF 1001-MM and 1001-MF, as well as curaplex REF 301-0318LT. These masks are packaged one per plastic pouch or thirty per case.
The recall was initiated after complaints were received indicating that the re-breather bag would not fill or inflate, or that the oxygen line would pop off after the oxygen is turned on due to a clogged port. The agency has classified this as a Class II recall.
Distribution of the affected units was made to California, Florida, Missouri, Ohio, and Pennsylvania. Consumers and healthcare facilities should stop using the affected masks and contact POM Medical LLC for instructions on return or replacement.
The recalled product
- Product
- POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, L
- Manufacturer
- POM Medical LLC
- Affected units
- 5,610
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 (7)
- Model 1001-MM - Lot numbers 021418-021421
- 032218-032221
- 032618-032621
- and 032818-032821
- Model KE1001-MM
- Model 301-0318LT - Lot numbers 022218-022221
- and Model 1001-MF - Lot number 032818-032821.
Distribution
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