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U.S. Department of Health and Human Services

Class 2 Device Recall Vista Dental Products ChlorXTRA

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 Class 2 Device Recall Vista Dental Products ChlorXTRAsee related information
Date Initiated by FirmJune 27, 2019
Date PostedOctober 01, 2019
Recall Status1 Terminated 3 on August 10, 2021
Recall NumberZ-0017-2020
Recall Event ID 83435
510(K)NumberK082470 
Product Classification Cleanser, root canal - Product Code KJJ
ProductVista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Code Information Lot/Work Order Numbers: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502  
Recalling Firm/
Manufacturer		 Inter-Med Llc
2200 Northwestern Ave
Racine WI 53404-2500
For Additional Information ContactKaty 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
ActionThe 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 Commerce384 units
DistributionUS, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KJJ
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