FDAFDA · Food and drugs·Recall number Z-0262-2020
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.
Published November 6, 2019 · Recall initiated: July 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- POM Medical LLC
- Distributor
- Distribution was made to CA, FL, MO, OH, and PA.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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