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FDAFDA · Food and drugs·Recall number Z-3044-2024

Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack

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
AM185B , Lot Number 23BBS790 ; AM185B , Lot Number 23IBT868 ; AM185B , Lot Number 23JBW874 ; AM185B , Lot Number 24ABQ730 ; CDS830039AF, Lot Number 19GBO514 ; CDS830039AF, Lot Number 19HBS937 ; CDS830039AF, Lot Number 19JBM007 ; CDS830039AF, Lot Number 19VBF341 ; CDS830039AF, Lot Number 20ABQ286 ; CDS830039AF, Lot Number 20BBR820 ; CDS830039AF, Lot Number 20CBC115 ; CDS830039AF, Lot Number 20EBC561 ; CDS830039AF, Lot Number 20FBH160 ; CDS830039AF, Lot Number 20GBG417 ; CDS830039AF, Lot Number 20GBT038 ; CDS830039AF, Lot Number 20JBA496 ; CDS830039AF, Lot Number 20LBV774 ; CDS830039AF, Lot Number 21ABJ105 ; CDS830039AI, Lot Number 21HBA287 ; CDS830039AI, Lot Number 21HBG893 ; CDS830039AI, Lot Number 21IBJ983 ; CDS830039AI, Lot Number 21LBQ697 ; CDS830039AI, Lot Number 22ABA249 ; CDS830039AI, Lot Number 22CBY819 ; CDS830039AI, Lot Number 22OBB223 ; CDS830039AI, Lot Number 21CBQ656 ; CDS830039AI, Lot Number 21DBP447 ; CDS830039AI, Lot Number 21FBH085 ; CDS830039AJ, Lot Number 22DBI098 ; CDS830039AJ, Lot Number 22EBN206 ; CDS830039AJ, Lot Number 22FBC480 ; CDS830039AJ, Lot Number 22FBD486 ; CDS830039AJ, Lot Number 22FBT263 ; CDS830039AJ, Lot Number 22FBW862 ; CDS830039AK, Lot Number 22JBF161 ; CDS830039AK, Lot Number 22KBQ120 ; CDS830039AK, Lot Number 22LBC150 ; CDS830039AK, Lot Number 23ABF855 ; CDS830039AK, Lot Number 23CBH440 ; CDS830039AK, Lot Number 23FBK921 ; CDS830039AK, Lot Number 23FBK922 ; CDS830039AK, Lot Number 23GBA194 ; CDS830039AK, Lot Number 23HBO379 ; CDS830039AK, Lot Number 23IBE023 ; CDS830039AK, Lot Number 23JBL894 ; CDS830039AK, Lot Number 23KBB125 ; CDS830053G , Lot Number 21HBR110 ; CDS830053G , Lot Number 21IBJ984 ; CDS830053G , Lot Number 21KBT291 ; CDS830053G , Lot Number 21KBW772 ; CDS830053G , Lot Number 22BBK560 ; CDS830053G , Lot Number 19ABC405 ; CDS830053G , Lot Number 22BBQ057 ; CDS830053G , Lot Number 19ABX756 ; CDS830053G , Lot Number 22OBE801 ; CDS830053G , Lot Number 19CBI663 ; CDS830053G , Lot Number 22DBN943 ; CDS830053G , Lot Number 19EBC550 ; CDS830053G , Lot Number 22GBA870 ; CDS830053G , Lot Number 19FBN913 ; CDS830053G , Lot Number 19HBZ072 ; CDS830053G , Lot Number 19IBI894 ; CDS830053G , Lot Number 19IBP482 ; CDS830053G , Lot Number 19JBP810 ; CDS830053G , Lot Number 19LBL676 ; CDS830053G , Lot Number 20ABL825 ; CDS830053G , Lot Number 20CBV686 ; CDS830053G , Lot Number 20FBN246 ; CDS830053G , Lot Number 20GBP178 ; CDS830053G , Lot Number 20IBC356 ; CDS830053G , Lot Number 20IBG769 ; CDS830053G , Lot Number 20LBV829 ; CDS830053G , Lot Number 21ABM101 ; CDS830053G , Lot Number 21BBA375 ; CDS830053G , Lot Number 21CBA201 ; CDS830053G , Lot Number 21CBB711 ; CDS830053I , Lot Number 22GBB014 ; CDS830053I , Lot Number 22IBJ347 ; CDS830053I , Lot Number 22JBP418 ; CDS830053I , Lot Number 22KBF644 ; CDS830053I , Lot Number 22KBS025 ; CDS830053I , Lot Number 23BBA669 ; CDS830053I , Lot Number 23BBJ070 ; CDS830053I , Lot Number 23BBN831 ; CDS830053I , Lot Number 23EBD612 ; CDS830053I , Lot Number 23FBA344 ; CDS830053I , Lot Number 23GBD900 ; CDS830053I , Lot Number 23IBJ528 ; CDS830053I , Lot Number 23IBS206 ; CDS830053I , Lot Number 23JBO100 ; CDS830053I , Lot Number 23KBR822 ; CDS830053I , Lot Number 24ABB121 ; CDS830053I , Lot Number 24BBN779 ; CDS830054P , Lot Number 21JBO031 ; CDS830054P , Lot Number 21JBX762 ; CDS830116T , Lot Number 21EMB670 ; CDS830116T , Lot Number 21GMA024 ; CDS830116T , Lot Number 21JMB604 ; CDS830116T , Lot Number 21JMF853 ; CDS830116T , Lot Number 21JMH576 ; CDS830116T , Lot Number 21LMF690 ; CDS830116T , Lot Number 22DMB054 ; CDS830116T , Lot Number 22DMI608 ; CDS830116T , Lot Number 22GMA496 ; CDS830116T , Lot Number 22HMG373 ; CDS830116T , Lot Number 22IME198 ; CDS830116T , Lot Number 22JMD253 ; CDS830116T , Lot Number 22KMF160 ; CDS830116T , Lot Number 22KMG955 ; CDS830116T , Lot Number 22LMD441 ; CDS830116T , Lot Number 23BME252 ; CDS830116T , Lot Num
Risk classification
Class II
Area (FDA)
device
Country
United States

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