FDAFDA · Food and drugs·Recall number Z-0976-2024
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Published February 14, 2024 · Recall initiated: December 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- G & H Wire Company
- Distributor
- 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.
- Lot
- UDI: 10195291042642 Lot Number: 1120035
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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