Z-0760-2017 Class II Terminated
FDA device recall Z-0760-2017 was initiated by Inovo, Inc on July 21, 2016 and is designated Class II. Reason for recall: Device can fail during operation. The recall status is terminated (terminated July 16, 2019). Affected quantity: 117 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- July 21, 2016
- Termination Date
- July 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117 units
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.
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.
Code Information
Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.