Device recall
Z-2058-2016: *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-2058-2016 |
|---|---|
| Recall event | 66372 |
| Product | *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; ***… |
| Product code | FPA |
| Recalling firm | Hospira Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2016 |
| 510(k) numbers | K103224 |
| FEI number | 3013319212 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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