Helix Medical LLC recalls BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Oc

Recalled September 19, 2012 · FDA recall Z-2336-2012 · Helix Medical

Hazard

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

Units

2 devices

Sold at

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

Description

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

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.

Manufacturer(s)

Helix Medical LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →