Z-2336-2012 Class III Terminated
FDA device recall Z-2336-2012 was initiated by Helix Medical LLC on March 8, 2012 and is designated Class III. Reason for recall: Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. The recall status is terminated (terminated April 2, 2013). Affected quantity: 2 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2012
- Initiation Date
- March 8, 2012
- Termination Date
- April 2, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices
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.
Reason for Recall
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Distribution Pattern
Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Code Information
Lot#1008419