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U.S. Department of Health and Human Services

Class 2 Device Recall Vista Dental Products Sodium Hypochlorite 3

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  Class 2 Device Recall Vista Dental Products Sodium Hypochlorite 3 see related information
Date Initiated by Firm June 27, 2019
Date Posted October 01, 2019
Recall Status1 Terminated 3 on August 10, 2021
Recall Number Z-0013-2020
Recall Event ID 83435
510(K)Number K082470  
Product Classification Cleanser, root canal - Product Code KJJ
Product Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Code Information Lot/Work Order Numbers: 2018-1349 2018-1587 2018-1853 20182107, UDI (01)10818207020427 20182303, UDI (01)10818207020427 20182584, UDI (01)10818207020427 20182666, UDI (01)10818207020427 20190199, UDI (01)10818207020427 20190433, UDI (01)10818207020427  
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 582 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.
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