Recall Z-0262-2020 ยท BYG Mask, Oxygen
POM Medical LLC
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 He
| Date | Jul 11, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated recall by telephone beginning 7/11/2018 requesting return of the product. |
| Quantity | 5,610 units |
| Distribution | Distribution was made to CA, FL, MO, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.