Device 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.
Z-2336-2012
Product summary
- Event
- Event 62970
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2 devices
- Official record key
device-enforcement:Z-2336-2012
Official wording
Reason: Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Code information: Lot#1008419
Distribution pattern: Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Derived failure modes
-
Unknown
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.