Device recall
Z-1065-2008: Non-continuous ventilator accessories under the following brand names: a)…
FDA device recall · Class II · Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1065-2008 |
|---|---|
| Recall event | 45545 |
| Product | Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S; d) REMStar Auto M. w/Smartcard, CNDA model… |
| Product code | BZD |
| Recalling firm | Respironics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2009 |
| 510(k) numbers | K041010, K052110 |
| FEI number | 2518422 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database