Vista Dental Products Chlor-XTRA recall
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Why was Vista Dental Products Chlor-XTRA 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?
Lot/Work Order Numbers: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502
- Product
- Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
- Recalling firm
- Inter-Med Llc
- Quantity
- 384 units
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)