FDAClass IIOctober 9, 2019

Vista Dental Products Chlor-XTRA recall

Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825

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?

UDI (01)10818207020496 Lot/Work Order Numbers: 20190565 20191107

Product
Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
Recalling firm
Inter-Med Llc
Quantity
58 units
Distribution
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Recall date
October 9, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls