Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825

FDA Recall Z-0016-2020 · Posted 2019-10-01

Recalling FirmInter-Med Llc
Recall StatusTerminated
Product CodeKJJ
Date Initiated2019-06-27
Date Terminated2021-08-10
Product Quantity58 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US, South Africa, Switzerland, Poland, Italy, Singapore, Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082470SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAInter-Med, Inc. · 2009-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑