Moorpark, CA, United States
POM Medical LLC recalls
1 recall recorded since 2018, most recently on 11 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 July 2018
- Terminated
- 4 January 2021
- 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.
- Distribution
- Distribution was made to CA, FL, MO, OH, and PA.
- Initiated
- Voluntary: Firm initiated
- 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 30
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.