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U.S. Department of Health and Human Services

Class 2 Device Recall Purefill Oxygen Compressor, model PF1100

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 Class 2 Device Recall Purefill Oxygen Compressor, model PF1100see related information
Date Initiated by FirmJuly 21, 2016
Create DateDecember 14, 2016
Recall Status1 Terminated 3 on July 16, 2019
Recall NumberZ-0760-2017
Recall Event ID 75312
510(K)NumberK141967 
Product Classification Generator, oxygen, portable - Product Code CAW
ProductINOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
Code Information Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
Recalling Firm/
Manufacturer		 Inovo, Inc
401 Leonard Blvd N
Lehigh Acres FL 33971-6302
For Additional Information ContactBetty Miller
814-443-7602
Manufacturer Reason
for Recall		Device can fail during operation.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm, Inovo, Inc, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated Sept 2, 2016 to all their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and isolate the devices in their inventory and return them to Inovo Inc. Also, if the consignee sold or distributed the device, the consignee needs to retrieve and return the units to Inovo Inc. as soon as possible and complete and return the Medical Device Return Response form in the self-addressed stamped envelope provided or email to: regulatory@inovoin.com or fax to Inovo, Inc. Any questions please contact at 814-443-7602 or via e-mail at regulatory@inovoinc.com.
Quantity in Commerce117 units
DistributionUS Nationwide Distribution to states of: AL, AR, CT, FL, IA, KS, KY, MD, MI, MN, MO, NE, NJ, NV, NY, OH, RI, SC, TN, TX, UT, and WA.
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.
510(K) Database510(K)s with Product Code = CAW
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