INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
FDA Recall Z-0760-2017 · Posted None
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Recalling FirmInovo, Inc
Recall StatusTerminated
Product CodeCAW
Date Initiated2016-07-21
Date Terminated2019-07-16
Product Quantity117 units
Reason for Recall
Device can fail during operation.
Firm Action
The 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: [email protected] or fax to Inovo, Inc.
Any questions please contact at 814-443-7602 or via e-mail at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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