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.
FDA Recall Z-2336-2012 · Posted 2012-09-07
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Recalling FirmHelix Medical LLC
Recall StatusTerminated
Product CodeEWL
Date Initiated2012-03-08
Date Terminated2013-04-02
Product Quantity2 devices
Reason for Recall
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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