Recall Z-0017-2020 ยท KJJ Cleanser, Root Canal
Inter-Med Llc
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
| Date | Oct 1, 2019 (initiated Jun 27, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions. |
| Quantity | 384 units |
| Distribution | US, South Africa, Switzerland, Poland, Italy, Singapore, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA Inter-Med, Inc., Apr 3, 2009 |