medical Class II Updated 2019-10-09

Inter-Med Llc recalls Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes,

Recalled Product

Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850


Hazard / Issue

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.

Issued by

FDA

Distribution: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Lot/Code Info: Lot/Work Order Numbers: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502
View official government recall

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