FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Summary
The FDA issued a Class II for FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, toot by G & H Wire Company. Reason: Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy.
Details
Source
Device Recall
External ID
Z-0976-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Lot/Code Info: UDI: 10195291042642 Lot Number: 1120035
Quantity Affected: 81 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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Franklin, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (G & H Wire Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does G & H Wire Company have FDA actions?
This is the only FDA action we have on record for G & H Wire Company in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0976-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29