Reported Nov 6, 2019 · Terminated
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows
POM Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: POM Medical LLC · 11959 Discovery Ct · Moorpark, CA · 93021-7120
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
1001-MM | Lot numbers 021418-021421, 032218-032221, 032618-032621, and 032818-032821 |
KE1001-MM | an internal number used by one of the distributors (same as 1001-MM) - Lot numbers 021418-021421 and 032818-032821 |
301-0318LT | Lot numbers 022218-022221, 032218-032221, 032618-032621 |
1001-MF | and - Lot number 032818-032821. |
- Amount recalled
- 5,610 units
Where it was sold
Why it was recalled
Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.
This product could cause temporary or reversible health problems — stop using it.
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