FDA Device recall Z-2336-2012
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved…
- FDA Device
- Class III
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class III recall of BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved… by Helix Medical, citing helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2336-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-08 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Helix Medical |
| Distribution | US |
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 TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
Reason
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Identifiers
| code_info | Lot#1008419 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2336-2012%22
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