Device recall
Z-2336-2012: BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer…
FDA device recall · Class III · Helix Medical LLC
Key facts
| Recall number (Z-number) | Z-2336-2012 |
|---|---|
| Recall event | 62970 |
| Product | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling… |
| Product code | EWL |
| Recalling firm | Helix Medical LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 2, 2013 |
| FEI number | 2025182 |
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