Recall Z-0760-2017— Inovo, Inc

Name: FDA recall Z-0760-2017
Creator: U.S. Food and Drug Administration
Published: 2016-07-21

Class II · Terminated

Class II FDA medical device recall by Inovo, Inc, initiated 2016-07-21, terminated 2019-07-16. It names one FDA 510(k) clearance: K141967. 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.. Reason: Device can fail during operation..

Recalling firm: Inovo, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-21
Terminated: 2019-07-16
Firm location: Lehigh Acres, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K141967 — PUREFILL OXYGEN COMPRESSORInovo, Inc.·cleared 2014-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Device can fail during operation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.