Recall Z-0760-2017
Inovo, Inc · initiated July 21, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
Reason for recall
Device can fail during operation.
FDA-determined cause: Under Investigation by firm
Action taken
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: regulatory@inovoin.com or fax to Inovo, Inc. Any questions please contact at 814-443-7602 or via e-mail at regulatory@inovoinc.com.
Details
- Recall number
- Z-0760-2017
- Initiated
- July 21, 2016
- Terminated
- July 16, 2019
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 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.
- Recalling firm
- Inovo, Inc, Lehigh Acres, FL