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
Portable Oxygen Generator - Product Code CAW
원인
Potential for sieve beds to have been incorrectly assembled.
조치
On 10/30/08, the recalling firm began to telephone customers of the problem. The recalling firm followed up with Urgent: Medical Device Recall letters, dated 11/7/2008. The letters requested that users cease the use of the affected device and immediately contact their provider to make arrangements to have the Concentrator replaced. The firm has set up a toll free line to assist customers with identification of affected units and the return process.
Model 515ADS - serial number range A561137DS - A562049DS; Model 515ADZ - serial number range A538908DZ - A538924DZ; Model 515AKS - serial number range A542879KS - A543722KS; and Model 515AKZ - serial number A501627KZ.
Worldwide Distribution --- USA including states of AL, CA, FL ,GA, IN, IL, MA, MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, and WI, and countries of Canada, Columbia, Germany, Mexico, Netherlands, Singapore, and United Kingdom.
제품 설명
DeVilbiss Model 515A Oxygen Concentrator || Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.