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
- Recall Number
- Z-0760-2017
- Event Number
- 75312
- Firm
- Inovo, Inc
- FEI Number
- 3000719543
- Product Code
- CAW
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 21, 2016
- Terminated
- July 16, 2019
- Address
- 401 Leonard Blvd N, Lehigh Acres, FL, 33971-6302
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.
Device can fail during operation.
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: [email protected] or fax to Inovo, Inc. Any questions please contact at 814-443-7602 or via e-mail at [email protected].
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.
117 units