FDAFDA · Food and drugs·Recall number Z-2336-2012
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.
Published September 19, 2012 · Recall initiated: March 8, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Helix Medical LLC
- Distributor
- Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
- Lot
- Lot#1008419
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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