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U.S. Department of Health and Human Services

Class 2 Device Recall POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask

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 Class 2 Device Recall POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Masksee related information
Date Initiated by FirmJuly 11, 2018
Create DateOctober 31, 2019
Recall Status1 Terminated 3 on January 04, 2021
Recall NumberZ-0262-2020
Recall Event ID 83540
Product Classification Mask, oxygen - Product Code BYG
ProductPOM 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.
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.
Recalling Firm/
Manufacturer		 POM Medical LLC
11959 Discovery Ct
Moorpark CA 93021-7120
For Additional Information ContactJoe Voss
855-766-0202
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm initiated recall by telephone beginning 7/11/2018 requesting return of the product.
Quantity in Commerce5,610 units
DistributionDistribution was made to CA, FL, MO, OH, and PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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