FDA-Device2022-12-21Class II
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Ethicon, Inc.
Hazard
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
Sold states
International (OUS) only: Canada, Japan, Australia and New Zealand
Affected count
7,560 eaches
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2023Don't want to check this manually?
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