Device recall
Z-2669-2014: Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The…
FDA device recall · Class II · Genesis BPS, LLC.
Key facts
| Recall number (Z-number) | Z-2669-2014 |
|---|---|
| Recall event | 68874 |
| Product | Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion. |
| Product code | BRZ |
| Recalling firm | Genesis BPS, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2016 |
| 510(k) numbers | K050805 |
| FEI number | 1000527169 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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