BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occlu

FDA device recall Z-2336-2012 · posted 2012-09-07 · Terminated

Recall details

Recalling firm

Helix Medical LLC

Reason for recall

Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.

Action taken

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

Status

Terminated

Product code

EWL

Quantity affected

2 devices

Distribution

Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom

Date initiated

2012-03-08

Date posted

2012-09-07

Date terminated

2013-04-02

Location

Carpinteria, CA