Device recall
Z-0976-2010: Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls…
FDA device recall · Class II · Sigma-Aldrich Mfg LLC
Key facts
| Recall number (Z-number) | Z-0976-2010 |
|---|---|
| Recall event | 53956 |
| Product | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077… |
| Product code | JCF |
| Recalling firm | Sigma-Aldrich Mfg LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2012 |
| FEI number | 1938173 |
At a glance
- None 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