Recall Z-2336-2012— Helix Medical LLC
Class III · Terminated
Class III FDA medical device recall by Helix Medical LLC, initiated 2012-03-08, terminated 2013-04-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date..
- Recalling firm
- Helix Medical LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-03-08
- Terminated
- 2013-04-02
- Firm location
- Carpinteria, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.