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Terminated

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.

FDA Recall Z-0262-2020 · Posted None

Recalling FirmPOM Medical LLC
Recall StatusTerminated
Product CodeBYG
Date Initiated2018-07-11
Date Terminated2021-01-04
Product Quantity5,610 units

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.

Firm Action

The firm initiated recall by telephone beginning 7/11/2018 requesting return of the product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution was made to CA, FL, MO, OH, and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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