FDA-Device2023-05-17Class II
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
Ethicon, Inc.
Hazard
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
Sold states
International distribution in the countries of United Kingdom, Ireland and Turkey.
Affected count
1,656 eaches (OUS only)
Manufactured in
1000 Route 202, N/A, Raritan, NJ, United States
Products
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1571-2023Don't want to check this manually?
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