medical Class II Updated 2019-11-06

POM Medical LLC recalls POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation,

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, FL, MO, OH, PA
Lot/Code Info: 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.
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