FDA-Device2025-04-09Class II
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Ethicon Endo Surgery, LLC
Hazard
Identified curing issues with the silicone during the needles manufacturing process.
Sold states
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.
Affected count
37,080 units
Manufactured in
475C - Suite 202, Guaynabo, PR, United States
Products
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1515-2025Don't want to check this manually?
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