Z-0760-2017Class II

INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen...

Name: Z-0760-2017 INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen...
Creator: Inovo, Inc
Published: 2016-07-21
License: https://open.fda.gov/license/

Inovo Inc. / initiated 2016-07-21 / Terminated

FDA source

Inovo, Inc began a recall of INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders on 2016-07-21. FDA classified it as Class II and gives the reason as "Device can fail during operation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0760-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-21
Posted: 2016-12-14
Terminated: 2019-07-16
Recalling firm: Inovo Inc.
Product: INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Device can fail during operation.
FDA root cause: Under Investigation by 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].
Quantity in commerce: 117 units
Distribution: 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.
Product codes and lots: Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0760-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0760-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code CAW

K141967Class IIPurefill Oxygen CompressorInovo, Inc. / cleared 2014-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)