DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be
FDA device recall Z-0617-2009 · posted 2008-12-30 · Terminated
Recall details
- Recalling firm
- Sunrise Medical
- Reason for recall
- potential for sieve beds to have been incorrectly assembled
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 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, Netherlan
- Date initiated
- 2008-10-30
- Date posted
- 2008-12-30
- Date terminated
- 2012-10-27
- Location
- Somerset, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS 5 LITER OXYGEN CONCENTRATOR (K991722) | Sunrise Medical Hhg, Inc. | 1999-11-03 |