Recall Z-0760-2017 ยท CAW Generator, Oxygen, Portable
Inovo, Inc
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
| Date | Jul 21, 2016 |
| Status | Terminated |
| Reason | Device can fail during operation. |
| 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: regulatory@inovoin.com |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141967 | PUREFILL OXYGEN COMPRESSOR Inovo, Inc., Nov 7, 2014 |