Date Initiated by Firm |
June 27, 2019 |
Date Posted |
October 01, 2019 |
Recall Status1 |
Terminated 3 on August 10, 2021 |
Recall Number |
Z-0016-2020 |
Recall Event ID |
83435 |
510(K)Number |
K082470
|
Product Classification |
Cleanser, root canal - Product Code KJJ
|
Product |
Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 |
Code Information |
UDI (01)10818207020496 Lot/Work Order Numbers: 20190565 20191107 |
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 |
58 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 and Original Applicant = INTER-MED, INC.
|