FLEXSelect 5/16" Amber Latex Elastics-Intended use is recall
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Why was FLEXSelect 5/16" Amber Latex Elastics-Intended use is recalled?
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 10195291042642 Lot Number: 1120035
- Product
- FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
- Recalling firm
- G & H Wire Company
- Quantity
- 81 pk (100/pk)
- Distribution
- 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.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)