FDA-Device2024-09-18Class II

Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number DYNDA1598C; 6) INTUBATION KIT , Pack Number DYNDA1598CH ; 7) ANESTHESIA KIT , Pack Number DYNDA2958; 8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758; 9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889;

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) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number DYNDA1598C; 6) INTUBATION KIT , Pack Number DYNDA1598CH ; 7) ANESTHESIA KIT , Pack Number DYNDA2958; 8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758; 9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889; 10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y; 11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B; 12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644; 13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B; 14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C; 15) AIRWAY PACK , Pack Number DYNJ60239B; 16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925; 17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ; 18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ; 19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ; 20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ; 21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ; 22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ; 23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ; 24) #######, Pack Number DYNJ905503F ; 25) MZ MDL AIRWAY, Pack Number DYNJ910129; 26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ; 27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572; 28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ; 31) ANESTHESIA KIT , Pack Number DYNJRA0424A ; 32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767; 33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ; 34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ; 35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ; 36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ; 37) ANESTHESIA TRAY, Pack Number DYNJRA0909; 38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ; 39) #####, Pack Number DYNJRA0955A ; 40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968; 41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119; 42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ; 43) ANESTHESIA TRAY, Pack Number DYNJRA1355; 44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ; 45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ; 46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659; 47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ; 48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757; 49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899; 50) ANESTHESIA TRAY, Pack Number DYNJRA1934; 51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087; 52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151; 53) PRE OP ANES KIT, Pack Number DYNJRA2228; 54) PRE OP ANES KIT, Pack Number DYNJRA2228H; 55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I; 56) REGIONAL TRAY, Pack Number PAIN0385B; 57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ; 58) CIRC PACK-LF, Pack Number PHS41720I; 59) CIRC PACK-LF, Pack Number PHS41720J; 60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2983-2024

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