FDA-Device2024-06-26Class II
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
Ethicon, Inc.
Hazard
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Sold states
Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
Affected count
55296 units
Manufactured in
1000 Route 202, N/A, Raritan, NJ, United States
Products
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2145-2024Don't want to check this manually?
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