Vista Dental Products Sodium Hypochlorite - 6% recall
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Why was Vista Dental Products Sodium Hypochlorite - 6% recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current 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 (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952
- Product
- Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
- Recalling firm
- Inter-Med Llc
- Quantity
- 768 units
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)