Device recall
Z-2234-2008: StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in…
FDA device recall · Class II · StatSpin, Inc., dba Iris Sample Processing
Key facts
| Recall number (Z-number) | Z-2234-2008 |
|---|---|
| Recall event | 48685 |
| Product | StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of capillary blood to prepare plasma/serum. |
| Product code | JKA |
| Recalling firm | StatSpin, Inc., dba Iris Sample Processing |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2012 |
| 510(k) numbers | K896206 |
| FEI number | 1221015 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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