FDA-Device2024-06-26Class II
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
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
306000 units
Manufactured in
1000 Route 202, N/A, Raritan, NJ, United States
Products
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2024Don't want to check this manually?
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