FDA Device recall Z-0262-2020
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Con…
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Con… by Pom Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0262-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-11 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pom Medical |
| Distribution | CA, FL, MO, OH, PA |
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, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
Reason
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.
Identifiers
| code_info | Model 1001-MM - Lot numbers 021418-021421, 032218-032221, 032618-032621, and 032818-032821; Model KE1001-MM, an inte…Model 1001-MM - Lot numbers 021418-021421, 032218-032221, 032618-032621, and 032818-032821; Model KE1001-MM, an internal number used by one of the distributors (same as 1001-MM) - Lot numbers 021418-021421 and 032818-032821; Model 301-0318LT - Lot numbers 022218-022221, 032218-032221, 032618-032621; and Model 1001-MF - Lot number 032818-032821. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0262-2020%22
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