FDA Enforcement
Class II
Terminated
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
Recall: Z-0760-2017
·
Reported December 21, 2016
Enforcement
- Recall Number
- Z-0760-2017
- Event ID
- 75312
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Inovo, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 21, 2016
- Initiation Date
- July 21, 2016
- Classification Date
- December 14, 2016
- Termination Date
- July 16, 2019
- Address
- 401 Leonard Blvd N, Lehigh Acres, FL, 33971-6302, United States
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
Device can fail during operation.
Code Info
Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
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.
Quantity
117 units