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U.S. Department of Health and Human Services

Class 3 Device Recall BLOMSINGER indwelling TEP Occluder

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  Class 3 Device Recall BLOMSINGER indwelling TEP Occluder see related information
Date Initiated by Firm March 08, 2012
Date Posted September 07, 2012
Recall Status1 Terminated 3 on April 02, 2013
Recall Number Z-2336-2012
Recall Event ID 62970
Product Classification Prosthesis, laryngeal (taub) - Product Code EWL
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.
Code Information Lot#1008419
Recalling Firm/
Manufacturer		 Helix Medical LLC
1110 Mark Ave
Carpinteria CA 93013-2918
For Additional Information Contact
805-684-3304
Manufacturer Reason
for Recall		 Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
FDA Determined
Cause 2		 Labeling mix-ups
Action A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to: Helix Medical, LLC Attn to: Customer Service-IN2004-TO. 1110 Mark Avenue Carpinteria, CA 93013 For questions regarding this recall call 805-684-3304.
Quantity in Commerce 2 devices
Distribution Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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