Device recall
Z-1139-2010: remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402…
FDA device recall · Class II · Remel, Inc
Key facts
| Recall number (Z-number) | Z-1139-2010 |
|---|---|
| Recall event | 54281 |
| Product | remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product is a sterile system recommended for use in qualitative procedures for the… |
| Product code | JSM |
| Recalling firm | Remel, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 510(k) numbers | K965152 |
| FEI number | 1924669 |
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