Z-2336-2012Class III

BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal...

Name: Z-2336-2012 BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal...
Creator: Helix Medical LLC
Published: 2012-03-08
License: https://open.fda.gov/license/

Freudenberg Medical, LLC / initiated 2012-03-08 / Terminated / root cause: labeling and UDI

FDA source

Helix Medical LLC began a recall of BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis... on 2012-03-08. FDA classified it as Class III and gives the reason as "Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2336-2012
Classification: Class III
Status: Terminated
Initiated: 2012-03-08
Posted: 2012-09-07
Terminated: 2013-04-02
Recalling firm: Freudenberg Medical, LLC
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.
Product code: EWL Prosthesis, Laryngeal (Taub)
Reason for recall: Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to: Helix Medical, LLC Attn to: Customer Service-IN2004-TO. 1110 Mark Avenue Carpinteria, CA 93013 For questions regarding this recall call 805-684-3304.
Quantity in commerce: 2 devices
Distribution: Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Product codes and lots: Lot#1008419

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2336-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2336-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07

Product code EWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)