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
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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
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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 |
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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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