Date Initiated by Firm | June 27, 2019 |
Date Posted | October 01, 2019 |
Recall Status1 |
Terminated 3 on August 10, 2021 |
Recall Number | Z-0014-2020 |
Recall Event ID |
83435 |
510(K)Number | K082470 |
Product Classification |
Cleanser, root canal - Product Code KJJ
|
Product | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 |
Code Information |
UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952 |
Recalling Firm/ Manufacturer |
Inter-Med Llc 2200 Northwestern Ave Racine WI 53404-2500
|
For Additional Information Contact | Katy Scott 414-639-9755 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 768 units |
Distribution | US, South Africa, Switzerland, Poland, Italy, Singapore, Australia |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = KJJ
|