FDA-Device2024-09-18Class II
Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Sold states
Worldwide distribution.
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ; 12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ; 13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ; 14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ; 15) ENDOSCOPY-LF, Pack Number DYNJ22890L ; 16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ; 17) ENDOSCOPY PACK, Pack Number DYNJ50594C ; 18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ; 19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ; 20) ENDOSCOPIC PACK , Pack Number DYNJ54221J ; 21) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478B ; 22) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478D ; 23) ENDO PACK , Pack Number DYNJ56043B ; 24) ENDO PACK , Pack Number DYNJ56043C ; 25) ENDO PACK, Pack Number DYNJ56043F; 26) ENDO PACK , Pack Number DYNJ56043F ; 27) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648B ; 28) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648C ; 29) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648D ; 30) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648J ; 31) ENDO / AUG PACK , Pack Number DYNJ59250A ; 32) ENDO / AUG PACK , Pack Number DYNJ59250B ; 33) PACK ENDO AAA HYBRIDCHRG, Pack Number DYNJ60126B ; 34) DIPASCO GENERAL ENDOCRINE PACK, Pack Number DYNJ60686A ; 35) ENDOSCOPIC PACK , Pack Number DYNJ63797; 36) ENDOSCOPY PACK, Pack Number DYNJ65524; 37) GENERAL ENDOSCOPIC PK , Pack Number DYNJ66034A ; 38) ENT ENDO SINUS WILMINGTON PACK, Pack Number DYNJ66447; 39) ENDOVENOUS PACK , Pack Number DYNJ66596; 40) GENERAL ENDOSCOPIC PACK , Pack Number DYNJ67382B ; 41) PEDI ENDO LAP PACK, Pack Number DYNJ68141; 42) GEN ENDOSCOPY , Pack Number DYNJ81490; 43) PACK ENDOSCOPIC CHOLECYSTE, Pack Number DYNJ81539; 44) ENDO UROLOGY, Pack Number DYNJ83704A ; 45) ENDOSCOPY , Pack Number DYNJ900509N; 46) ENDOSCOPY , Pack Number DYNJ900509O; 47) ENDO OMH, Pack Number DYNJ900525C; 48) MODULE ENDO LAP , Pack Number DYNJ903026F; 49) MODULE ENDO LAP , Pack Number DYNJ903026G; 50) GENERAL ENDOSCOPY , Pack Number DYNJ903421D; 51) CYSTO , Pack Number DYNJ903521A; 52) GENERAL ENDOSCOPY , Pack Number DYNJ903826F; 53) ENDO, Pack Number DYNJ904836A; 54) ENDO, Pack Number DYNJ904836B; 55) ENDO, Pack Number DYNJ904836C; 56) ENDO, Pack Number DYNJ904836D; 57) DIPASCO GENERAL ENDOCRINE , Pack Number DYNJ906574 ; 58) ENDOSCOPIC SKULL BASE , Pack Number DYNJ908362B; 59) ENDOSCOPY KIT , Pack Number P830355A ; 60) ENDOSCOPY KIT , Pack Number P830355AH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3009-2024Don't want to check this manually?
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