Z-0262-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- July 11, 2018
- Termination Date
- January 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,610 units
Product Description
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 for Recall
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.
Distribution Pattern
Distribution was made to CA, FL, MO, OH, and PA.
Code Information
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.