FDA-Device2024-06-26Class II
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
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
56952 units
Manufactured in
1000 Route 202, N/A, Raritan, NJ, United States
Products
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2024Don't want to check this manually?
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