U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Generator, oxygen, portable - Product Code CAW
원인
Device can fail during operation.
조치
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.
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.
제품 설명
INOVO Purefill Oxygen Compressor Model PF1100 || Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.