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Open, Classified

FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

FDA Recall Z-0976-2024 · Posted 2024-02-02

Recalling FirmG & H Wire Company
Recall StatusOpen, Classified
Product CodeECI
Date Initiated2023-12-21
Product Quantity81 pk (100/pk)

Reason for Recall

Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

Firm Action

G&H Orthodontics issued Product Recall Notice to customers on 12/21/23 via E-mail and phone call. Letter states reason for recall, health risk and action to take: Required Action for Users: Return product for disposal. Follow-up Actions by G&H: Flexmedics intends to replace products with accurately labeled products. You may reach G&H at 1.800.526.1026 or 1.31 7.346.6655 if you have additional questions. We are open 7 AM - 7PM US Eastern Time weekdays

Root Cause

Packaging process control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and the countries of Canada, France, Germany, New Zealand, South Africa, Thailand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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