medical MODERATE Updated 2019-10-09

Inter-Med Llc recalls Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, Q

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Recalled Product

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

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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall