Device recall
Z-1058-2013: Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in…
FDA device recall · Class I · Engineered Medical Systems,Inc
Key facts
| Recall number (Z-number) | Z-1058-2013 |
|---|---|
| Recall event | 64751 |
| Product | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. . |
| Product code | BSJ |
| Recalling firm | Engineered Medical Systems,Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 2, 2013 |
| 510(k) numbers | K874746 |
| FEI number | 1832562 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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