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FDAFDA · Food and drugs·Recall number Z-3051-2024

Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num

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
ACC010647A , Lot Number 23CDC070 ; ACC010647A , Lot Number 23DDA683 ; CDS760053K , Lot Number 22HBP517 ; CDS760053K , Lot Number 22HBS797 ; CDS760053K , Lot Number 22LBS190 ; CDS760053K , Lot Number 23ABC154 ; CDS760053K , Lot Number 23ABM789 ; CDS760053K , Lot Number 23EBB486 ; CDS760053K , Lot Number 23IBP664 ; CDS810010J , Lot Number 19BBU744 ; CDS810010J , Lot Number 19DBL815 ; CDS810010J , Lot Number 19FBH859 ; CDS810010J , Lot Number 19HBO222 ; CDS810010J , Lot Number 19IBG752 ; CDS810010J , Lot Number 20BBT732 ; CDS810010J , Lot Number 20CBY376 ; CDS810010J , Lot Number 20EBA044 ; CDS810010J , Lot Number 20FBF639 ; CDS810010J , Lot Number 21DBT774 ; CDS810010K , Lot Number 21IBI534 ; CDS810010K , Lot Number 21JBM642 ; CDS810010K , Lot Number 21KBT225 ; CDS810010K , Lot Number 21KBY732 ; CDS810010K , Lot Number 21LBJ661 ; CDS810010K , Lot Number 22BBT607 ; CDS810010K , Lot Number 22FBG549 ; CDS810010K , Lot Number 22FBG555 ; CDS810010K , Lot Number 22HBF177 ; CDS810010K , Lot Number 23DBF386 ; CDS810010K , Lot Number 23IBF920 ; CDS810010K , Lot Number 23KBF043 ; CDS810010K , Lot Number 23KBW104 ; CDS810010K , Lot Number 23KBW105 ; CDS810010K , Lot Number 24ABB073 ; CDS810023G, Lot Number 20DBK652; CDS810023G, Lot Number 20DBA257; CDS810023I, Lot Number 21GBP393; CDS810023I, Lot Number 21FBE254; CDS810023I, Lot Number 21BBS695; CDS810023I, Lot Number 20WBE729; CDS810023I, Lot Number 20IBG098; CDS810023I, Lot Number 20GBU914; CDS810023J, Lot Number 23JBI899; CDS810023J, Lot Number 23EBQ471; CDS810023J, Lot Number 23DBI051; CDS810023J, Lot Number 23BBU273; CDS810023J, Lot Number 23BBQ482; CDS810023J, Lot Number 23ABB691; CDS810023J, Lot Number 22LBF785; CDS810023J, Lot Number 22IBG219; CDS810023J, Lot Number 22HBR137; CDS810023J, Lot Number 22GBK847; CDS810023J, Lot Number 22EBS465; CDS810023J, Lot Number 22BBF452; CDS810023J, Lot Number 21LBI699; CDS810023J, Lot Number 21JBQ842; CDS810023K, Lot Number 23KBS455; CDS810032L , Lot Number 19BBP945 ; CDS810032L , Lot Number 19DBE971 ; CDS810032L , Lot Number 19FBJ782 ; CDS810032L , Lot Number 19FBZ139 ; CDS810032L , Lot Number 19IBP875 ; CDS810032L , Lot Number 19VBC448 ; CDS810032L , Lot Number 19KBO504 ; CDS810032L , Lot Number 20BBE593 ; CDS810032L , Lot Number 20DBB545 ; CDS810032L , Lot Number 20FBW326 ; CDS810032L , Lot Number 20HBU689 ; CDS810032L , Lot Number 21ABS929 ; CDS810032L , Lot Number 21BBF822 ; CDS810032M , Lot Number 21GBD880 ; CDS810032M , Lot Number 21GBP404 ; CDS810032M , Lot Number 21KBZ708 ; CDS810032M , Lot Number 22EBB266 ; CDS810032M , Lot Number 22EBC215 ; CDS810032M , Lot Number 22GBF284 ; CDS810032M , Lot Number 21EBC853 ; CDS810032M , Lot Number 21FBG299 ; CDS810032N , Lot Number 22HBI825 ; CDS810032N , Lot Number 22JBC455 ; CDS810032N , Lot Number 22KBM259 ; CDS810032N , Lot Number 23ABJ740 ; CDS810032N , Lot Number 23BBF830 ; CDS810032N , Lot Number 23BBG484 ; CDS810032O , Lot Number 23CBX494 ; CDS810032O , Lot Number 23EBB627 ; CDS810032O , Lot Number 23HBS135 ; CDS810032O , Lot Number 23JBN138 ; CDS810032O , Lot Number 23LBH820 ; CDS810032O , Lot Number 24CBC478 ; CDS981693I , Lot Number 21BBD922 ; CDS981693I , Lot Number 21CBU573 ; CDS981693I , Lot Number 21DBA609 ; CDS981693I , Lot Number 19AKC609 ; CDS981693I , Lot Number 19CKC217 ; CDS981693I , Lot Number 19EKC233 ; CDS981693I , Lot Number 19GKC208 ; CDS981693I , Lot Number 19IKA370 ; CDS981693I , Lot Number 19LKB506 ; CDS981693I , Lot Number 20BKA414 ; CDS981693I , Lot Number 20EKA431 ; CDS981693I , Lot Number 20HKA662 ; CDS981693I , Lot Number 20IKB479 ; CDS981693J , Lot Number 21JBE505 ; CDS981693J , Lot Number 21LBT097 ; CDS981693J , Lot Number 22BBE157 ; CDS981693J , Lot Number 22DBO666 ; CDS981693J , Lot Number 22FBT390 ; CDS981693J , Lot Number 22GBK042 ; CDS981693J , Lot Number 22HBP398 ; CDS981693J , Lot Number 22JBR298 ; CDS981693J , Lot Number 22LBM190 ; CDS981693J , L
Risk classification
Class II
Area (FDA)
device
Country
United States

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