Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
FDA device recall Z-0016-2020 · posted 2019-10-01 · Terminated
Recall details
- Recalling firm
- Inter-Med Llc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KJJ
- Quantity affected
- 58 units
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Date initiated
- 2019-06-27
- Date posted
- 2019-10-01
- Date terminated
- 2021-08-10
- Location
- Racine, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA (K082470) | Inter-Med, Inc. | 2009-04-03 |