FDAFDA · Food and drugs·Recall number Z-3009-2024
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
Published September 18, 2024 · Recall initiated: April 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution.
- Lot
- CDS981309O , Lot Number 19GBS426 ; CDS981309O , Lot Number 19JBE731 ; CDS981309O , Lot Number 19LBN327 ; CDS981309O , Lot Number 20BBE553 ; CDS981309O , Lot Number 20DBG947 ; CDS981309O , Lot Number 20GBU396 ; CDS984155F , Lot Number 19GBV870 ; CDS984155F , Lot Number 19JBX096 ; DYKE1112 , Lot Number 23LME611 ; DYKE1133A, Lot Number 22AMA243 ; DYKE1264 , Lot Number 22GME430 ; DYKE1264 , Lot Number 22HMA299 ; DYKE1389 , Lot Number 19DBL730 ; DYKE1389 , Lot Number 19DBN769 ; DYKE1389 , Lot Number 19VBA308 ; DYKE1389 , Lot Number 19KBI635 ; DYKE1389 , Lot Number 20ABU603 ; DYKE1856 , Lot Number 22JBU738 ; DYKE1856 , Lot Number 22LBC945 ; DYKE1856 , Lot Number 23ABJ226 ; DYKE1864B, Lot Number 23LBG919 ; DYNDA3058, Lot Number 23GBJ275 ; DYNDA3058, Lot Number 23JBJ971 ; DYNDA3058, Lot Number 23LBA980 ; DYNJ00339J , Lot Number 19LMB920 ; DYNJ00339J , Lot Number 20BMA093 ; DYNJ00339J , Lot Number 19DKA281 ; DYNJ00339J , Lot Number 19DKC903 ; DYNJ00339J , Lot Number 19GKA519 ; DYNJ00339J , Lot Number 19JKB148 ; DYNJ0396027I , Lot Number 19DDA509 ; DYNJ0426277J , Lot Number 19IMB754 ; DYNJ0426277J , Lot Number 20AMA124 ; DYNJ0426277J , Lot Number 20CMC692 ; DYNJ0426277J , Lot Number 20FMB816 ; DYNJ0426277J , Lot Number 20HMB568 ; DYNJ0426277J , Lot Number 20IMD473 ; DYNJ0426277J , Lot Number 21AMB951 ; DYNJ0426277J , Lot Number 21CMC718 ; DYNJ0426277J , Lot Number 21FMB061 ; DYNJ0426277J , Lot Number 19HKC356 ; DYNJ22661L , Lot Number 19HBO860 ; DYNJ22661L , Lot Number 19IBM436 ; DYNJ22661L , Lot Number 19JBQ066 ; DYNJ22661L , Lot Number 19KBK813 ; DYNJ22661L , Lot Number 19LBU575 ; DYNJ22661L , Lot Number 20BBX496 ; DYNJ22661L , Lot Number 20DBB020 ; DYNJ22661L , Lot Number 20GMC054 ; DYNJ22661L , Lot Number 20IMA806 ; DYNJ22661L , Lot Number 20IMC442 ; DYNJ22661L , Lot Number 20KMA517 ; DYNJ22661L , Lot Number 20LMF851 ; DYNJ22661L , Lot Number 21CMC664 ; DYNJ22661L , Lot Number 21HMA104 ; DYNJ22661L , Lot Number 21HMD574 ; DYNJ22661L , Lot Number 21IME853 ; DYNJ22661O , Lot Number 23GMB192 ; DYNJ22661O , Lot Number 23HMD182 ; DYNJ22661O , Lot Number 23IMG591 ; DYNJ22890L , Lot Number 19DBH535 ; DYNJ22890L , Lot Number 19EBT736 ; DYNJ22890L , Lot Number 19FBX264 ; DYNJ44673G , Lot Number 22IDB664 ; DYNJ44673G , Lot Number 22JDB619 ; DYNJ44673G , Lot Number 22KDB136 ; DYNJ44673G , Lot Number 22KDC145 ; DYNJ44673G , Lot Number 22LDA396 ; DYNJ44673G , Lot Number 23CDC115 ; DYNJ44673G , Lot Number 23DDB896 ; DYNJ44673G , Lot Number 23EDB560 ; DYNJ44673G , Lot Number 23GDB181 ; DYNJ44673G , Lot Number 23KDA313 ; DYNJ44673G , Lot Number 24ADA583 ; DYNJ44673G , Lot Number 24ADB767 ; DYNJ44673G , Lot Number 24BDB676 ; DYNJ50594C , Lot Number 19IBX922 ; DYNJ50594C , Lot Number 19JBY497 ; DYNJ50594C , Lot Number 20CBA891 ; DYNJ50594C , Lot Number 20DBQ243 ; DYNJ50594C , Lot Number 20EBR005 ; DYNJ50594C , Lot Number 20HBB011 ; DYNJ50594C , Lot Number 20HBM366 ; DYNJ50594C , Lot Number 21ABG167 ; DYNJ50594C , Lot Number 21BBN822 ; DYNJ50594C , Lot Number 21CBE742 ; DYNJ54221B , Lot Number 19RBA244 ; DYNJ54221B , Lot Number 19GBS216 ; DYNJ54221B , Lot Number 19HBJ331 ; DYNJ54221B , Lot Number 19HBL555 ; DYNJ54221C , Lot Number 19JBQ044 ; DYNJ54221C , Lot Number 19KBB653 ; DYNJ54221C , Lot Number 19LBS870 ; DYNJ54221C , Lot Number 20ABU331 ; DYNJ54221C , Lot Number 20BBL702 ; DYNJ54221C , Lot Number 20EBE847 ; DYNJ54221C , Lot Number 20EBK160 ; DYNJ54221J , Lot Number 23HBL781 ; DYNJ54221J , Lot Number 23JBW829 ; DYNJ54221J , Lot Number 23LBF338 ; DYNJ55478B , Lot Number 21GBP757 ; DYNJ55478B , Lot Number 21JBO286 ; DYNJ55478B , Lot Number 21JBO302 ; DYNJ55478B , Lot Number 21LBD900 ; DYNJ55478B , Lot Number 21LBS328 ; DYNJ55478B , Lot Number 22ABL817 ; DYNJ55478B , Lot Number 22ABU347 ; DYNJ55478B , Lot Number 19ABF658 ; DYNJ55478B , Lot Number 22BBT857 ; DYNJ55478B , Lot Number 19BBS313 ; DYNJ55478B , Lot Number 22OBG299 ; DYNJ55478B , L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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