FDAFDA · Food and drugs·Recall number Z-0014-2020
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Published October 9, 2019 · Recall initiated: June 27, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Inter-Med Llc
- Distributor
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Lot
- UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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