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FDAFDA · Food and drugs·Recall number Z-2997-2024

Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ; 6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ; 7) AV FISTULA PACK , Pack Number CDS840188M ; 8) VP SHUNT, Pack Number CDS840193V ; 9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ; 10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ; 11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH; 12) CENTRAL LINE CDS, Pack Number CDS930092V ; 13) CENTRAL LINE CDS, Pack Number CDS930092W ; 14) CENTRAL LINE CDS, Pack Number CDS930092X ; 15) C LINE INSERTION CDS, Pack Number CDS980379I ; 16) C LINE INSERTION CDS, Pack Number CDS980379J ; 17) AV FISTULA - SMH, Pack Number CDS980916L ; 18) AV FISTULA CDS, Pack Number CDS981513G ; 19) VASCULAR ACCESS CDS , Pack Number CDS981552F ; 20) VP SHUNT CDS, Pack Number CDS981740G ; 21) VP SHUNT CDS, Pack Number CDS981740I ; 22) PORT A CATH , Pack Number CDS982047Q ; 23) SHY VP SHUNT CDS, Pack Number CDS982389J; 24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ; 25) A-V FISTULA , Pack Number CDS982637K ; 26) A-V FISTULA , Pack Number CDS982637L ; 27) VASCULAR TRAUMA , Pack Number CDS982641K ; 28) AV FISTULA CDS, Pack Number CDS982660G ; 29) AV FISTULA CDS, Pack Number CDS982660I ; 30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ; 31) AV FISTULA/ACCESS , Pack Number CDS983060I ; 32) AV FISTULA/ACCESS , Pack Number CDS983060J ; 33) AV SHUNT CDS, Pack Number CDS983098B ; 34) AV SHUNT CDS, Pack Number CDS983098C ; 35) VASCULAR ACCESS CDS , Pack Number CDS983105C ; 36) VP SHUNT, Pack Number CDS983366K ; 37) VP SHUNT, Pack Number CDS983366L ; 38) AV FISTULA, Pack Number CDS983638G ; 39) AV FISTULA, Pack Number CDS983638I ; 40) AV FISTULA, Pack Number CDS983638J ; 41) BARIATRIC CDS , Pack Number CDS983657J ; 42) BARIATRIC CDS , Pack Number CDS983657K ; 43) BARIATRIC CDS , Pack Number CDS983883C ; 44) GROTH AV FISTULA CDS, Pack Number CDS984191P ; 45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ; 46) GROTH AV FISTULA CDS, Pack Number CDS984191S ; 47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ; 48) GROTH LASER VEIN, Pack Number CDS984193R; 49) SHY AV FISTULA CDS, Pack Number CDS984512G ; 50) AV FISTULA, Pack Number CDS985510G ; 51) THORACOSTOMY TRAY , Pack Number CHT2010; 52) TRAUMA CHEST TUBE SET , Pack Number CHT2015; 53) BARD MYPICC$ KIT, Pack Number CK000234A; 54) BARD MYPICC$ KIT, Pack Number CK000236A; 55) BARD MYPICC$ KIT, Pack Number CK000324 ; 56) BARD MYPICC$ KIT, Pack Number CK000325 ; 57) BARD MYPICC$ KIT, Pack Number CK000645A; 58) BARD MYPICC$ KIT, Pack Number CK000646A; 59) BARD MYPICC$ KIT, Pack Number CK000647A; 60) BARD MYPICC$ KIT, Pack Number CK000713 ; 61) BARD MYPICC$ KIT, Pack Number CK000714 ; 62) CENTRAL LINE TRAY , Pack Number CVI4705; 63) CVC INSERTION PACK, Pack Number CVI4720; 64) ****, Pack Number CVI4720B ; 65) KIT LINE INSERTION, Pack Number CVI4730; 66) KIT LINE INSERTION, Pack Number CVI4730A ; 67) VENOUS ACCESS TRAY, Pack Number CVI4830B ; 68) PORT INSERTION PACK , Pack Number CVI4870; 69) MVHS CVC LUMEN TRAY , Pack Number CVI4920; 70) NO CATHETER BUNDLE, Pack Number CVI4925A ; 71) UAMS PORT INSERTION KIT , Pack Number CVI5040; 72) CVL INSERTION PACK, Pack Number CVI5065; 73) CVL INSERTION PACK, Pack Number CVI5065H ; 74) HEMODIALYSIS TRAY , Pack Number DT8800 ; 75) ERCP KIT, Pack Number DYKE1006A; 76) PULMONARY KIT , Pack Number DYKE1870 ; 77) PULMONARY KIT, Pack Number DYKE1870H; 78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A; 79) ULTRASOUND PACK , Pack Number DYNDA1249A ; 80) CT SCAN-TC, Pack Number DYNDA1380A ; 81) CT SCAN-TC, Pack Number DYNDA1380AH; 82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077; 83) BAL KIT , Pack Number DYNDA2137B ; 84) STERILE PRE OP PACK , Pack Number

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
00-401649G , Lot Number 19IMB453 ; 00-401649G , Lot Number 19KMA787 ; 00-401649G , Lot Number 19LMC950 ; 00-401649G , Lot Number 20EMA317 ; 00-401649G , Lot Number 20EMC074 ; 00-401649G , Lot Number 20HMA234 ; 00-401649G , Lot Number 20JME695 ; 00-401649G , Lot Number 20LME609 ; 00-401649G , Lot Number 21BME658 ; 00-401649G , Lot Number 21CMB025 ; 00-401649G , Lot Number 21CMD185 ; 00-401649G , Lot Number 21DMA102 ; 00-401649G , Lot Number 21JMA649 ; 00-401649G , Lot Number 21JMF121 ; 00-401649G , Lot Number 19BKC121 ; 00-401649G , Lot Number 19CKD014 ; 00-401649G , Lot Number 19EKA045 ; 00-401649G , Lot Number 19GKA016 ; 00-401649G , Lot Number 19HKB535 ; 00-401649G , Lot Number 19IKB266 ; 00-401993O , Lot Number 23JBF090 ; 00-401993O , Lot Number 23KBH528 ; 00-401993O , Lot Number 23LBO811 ; 00-402001T , Lot Number 21GBL509 ; 00-402001T , Lot Number 21JBN647 ; 00-402001T , Lot Number 21JBZ697 ; 00-402001T , Lot Number 22BBX248 ; 00-402001T , Lot Number 22DBL467 ; 00-402001T , Lot Number 22DBS962 ; 00-402001T , Lot Number 22GBC939 ; 00-402001T , Lot Number 22HBO291 ; 00-402001T , Lot Number 22HBO322 ; 00-402001T , Lot Number 22IBN444 ; 00-402001T , Lot Number 22IBO023 ; 00-402001T , Lot Number 22KBT315 ; 00-402001T , Lot Number 23BBA151 ; 00-402001T , Lot Number 23CBI235 ; 00-402001T , Lot Number 23DBM140 ; 00-402001T , Lot Number 23EBT729 ; 00-402001T , Lot Number 23GBR995 ; 00-402001T , Lot Number 23GBS336 ; 00-402001U , Lot Number 23JBU819 ; 00-402001U , Lot Number 23LBG449 ; A134-MAX , Lot Number 19BKA379 ; A134-MAX , Lot Number 19DKB704 ; A134-MAX , Lot Number 19HKA891 ; A134-MAX , Lot Number 19KKA912 ; A134-MAX , Lot Number 19KKB286 ; A134-MAX , Lot Number 19KKB345 ; A134-MAX , Lot Number 20BKA796 ; A134-MAX , Lot Number 20EKA291 ; A134-MAX , Lot Number 20FKA121 ; A134-MAX , Lot Number 20FKB492 ; ARTNC175 , Lot Number 24AMF171 ; CDS840188M , Lot Number 21GME281 ; CDS840188M , Lot Number 21HMG887 ; CDS840188M , Lot Number 21LMG878 ; CDS840188M , Lot Number 22DMC877 ; CDS840188M , Lot Number 22FMF061 ; CDS840188M , Lot Number 22HMA885 ; CDS840188M , Lot Number 22HMG503 ; CDS840188M , Lot Number 22LMC521 ; CDS840188M , Lot Number 23JMC244 ; CDS840188M , Lot Number 23LMH857 ; CDS840188M , Lot Number 19DKC523 ; CDS840188M , Lot Number 19FKB927 ; CDS840188M , Lot Number 19GKC786 ; CDS840188M , Lot Number 19IKA428 ; CDS840188M , Lot Number 19LKB624 ; CDS840188M , Lot Number 20CKA278 ; CDS840188M , Lot Number 20EKB674 ; CDS840188M , Lot Number 20GKA668 ; CDS840188M , Lot Number 20IKA403 ; CDS840188M , Lot Number 20LKB098 ; CDS840188M , Lot Number 21CKA368 ; CDS840193V , Lot Number 21HBE520 ; CDS840193V , Lot Number 21HBE521 ; CDS840193V , Lot Number 21HBH244 ; CDS840193V , Lot Number 21JBE527 ; CDS840193V , Lot Number 21KBE066 ; CDS840193V , Lot Number 22ABM907 ; CDS840193V , Lot Number 22MBA145 ; CDS840193V , Lot Number 22DBP331 ; CDS840193V , Lot Number 22EBM213 ; CDS840193V , Lot Number 22EBN031 ; CDS840193V , Lot Number 22EBR456 ; CDS840193V , Lot Number 22GBU281 ; CDS840193V , Lot Number 23DBO524 ; CDS840193V , Lot Number 23EBW686 ; CDS840193V , Lot Number 23FBO564 ; CDS840193V , Lot Number 23IBQ501 ; CDS840193V , Lot Number 23JBD094 ; CDS840193V , Lot Number 23JBW804 ; CDS840193V , Lot Number 23JBX015 ; CDS840193V , Lot Number 21FBC630 ; CDS840295G , Lot Number 21FBN182 ; CDS840295G , Lot Number 21HBB477 ; CDS840295G , Lot Number 21HBB479 ; CDS840295G , Lot Number 21IBK120 ; CDS840295G , Lot Number 21JBU314 ; CDS840295G , Lot Number 21LBO663 ; CDS840295G , Lot Number 22OBI226 ; CDS840295G , Lot Number 22OBL670 ; CDS840295G , Lot Number 22GBA989 ; CDS840295G , Lot Number 22GBA991 ; CDS840295G , Lot Number 22GBA994 ; CDS840295G , Lot Number 19RBD411 ; CDS840295G , Lot Number 22HBQ573 ; CDS840295G , Lot Number 22IBE716 ; CDS840295G , Lot Number 19IBD862 ; CDS840295G , Lot Number 19IBJ104 ; CDS840295G , Lot Number 19
Risk classification
Class II
Area (FDA)
device
Country
United States

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