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Identified curing issues with the silicone during the needles manufacturing process.
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2025