Device recall
Z-0977-2010: Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and…
FDA device recall · Class II · Sigma-Aldrich Mfg LLC
Key facts
| Recall number (Z-number) | Z-0977-2010 |
|---|---|
| Recall event | 53956 |
| Product | Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. The product is for use in separating mononuclear cells and granulocytes when used with 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