Helix Medical LLC: Medical Device Recall in 2012 - (Recall #: Z-2336-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: March 8, 2012

Date Posted: September 19, 2012

Recall Number: Z-2336-2012

Event ID: 62970

Reason for Recall:

Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.

Status: Terminated

Product Quantity: 2 devices

Code Information:

Lot#1008419

Distribution Pattern:

Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated