Recall Z-0617-2009 ยท CAW Generator, Oxygen, Portable
Sunrise Medical
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.
| Date | Dec 30, 2008 (initiated Oct 30, 2008) |
| Status | Terminated |
| Reason | potential for sieve beds to have been incorrectly assembled |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 428 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991722 | DEVILBISS 5 LITER OXYGEN CONCENTRATOR Sunrise Medical Hhg, Inc., Nov 3, 1999 |