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FDAFDA · Food and drugs·Recall number Z-3048-2024

Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack Number CDS820081L ; 7) C-SECTION CDS , Pack Number CDS820103J ; 8) C-SECTION CDS , Pack Number CDS820103K ; 9) UVALDE C-SECTION CDS, Pack Number CDS820116F ; 10) UVALDE C-SECTION CDS, Pack Number CDS820116G ; 11) C-SECTION CDS , Pack Number CDS820136O ; 12) C-SECTION CDS , Pack Number CDS820136P ; 13) C-SECTION CDS , Pack Number CDS820136Q ; 14) C-SECTION CDS , Pack Number CDS820136R ; 15) C-SECTION CDS , Pack Number CDS820136S ; 16) C-SECTION CDS , Pack Number CDS820136T ; 17) C-SECTION CDS , Pack Number CDS820136U ; 18) C-SECTION CDS , Pack Number CDS820152F ; 19) C-SECTION CDS , Pack Number CDS820152G ; 20) C-SECTION CDS , Pack Number CDS820152I ; 21) C-SECTION CDS , Pack Number CDS980774J ; 22) C-SECTION , Pack Number CDS980774K ; 23) C-SECTION , Pack Number CDS980774L ; 24) C-SECTION , Pack Number CDS980774M ; 25) C-SECTION CDS WOR-LF, Pack Number CDS981707F ; 26) C-SECTION CDS , Pack Number CDS981777L ; 27) C-SECTION CDS , Pack Number CDS981777M ; 28) C-SECTION CDS , Pack Number CDS981777N ; 29) C-SECTION CDS-LF, Pack Number CDS982258F ; 30) C-SECTION CDS-LF, Pack Number CDS982258G ; 31) C-SECTION CDS-LF, Pack Number CDS982258I ; 32) C-SECTION CDS , Pack Number CDS982267F ; 33) C-SECTION CDS , Pack Number CDS982267G ; 34) C-SECTION CDS , Pack Number CDS982267I ; 35) C-SECTION CDS , Pack Number CDS982267J ; 36) C-SECTION CDS , Pack Number CDS982328J ; 37) C-SECTION CDS , Pack Number CDS982328K ; 38) C-SECTION CDS , Pack Number CDS982328L ; 39) C-SECTION CDS , Pack Number CDS982328M ; 40) C-SECTION CDS , Pack Number CDS982328O ; 41) C-SECTION CDS , Pack Number CDS982328P ; 42) C-SECTION CDS , Pack Number CDS982367G ; 43) C-SECTION COMBINED CDS, Pack Number CDS982398G ; 44) C-SECTION COMBINED CDS, Pack Number CDS982398I ; 45) C-SECTION CDS , Pack Number CDS982416O ; 46) C SECTION CDS CHS , Pack Number CDS982739F ; 47) C SECTION CDS CHS , Pack Number CDS982739J ; 48) C-SECTION CDS , Pack Number CDS983117C ; 49) C-SECTION CDS , Pack Number CDS983117D ; 50) C-SECTION CDS , Pack Number CDS983117F ; 51) C-SECTION CDS , Pack Number CDS983117G ; 52) C-SECTION PROCEDURE , Pack Number CDS983450I ; 53) C-SECTION PROCEDURE , Pack Number CDS983450J ; 54) C-SECTION PROCEDURE , Pack Number CDS983450K ; 55) C-SECTION PROCEDURE , Pack Number CDS983450L ; 56) C-SECTION PROCEDURE , Pack Number CDS983450M ; 57) C-SECTION CDS , Pack Number CDS983523D ; 58) C-SECTION CDS , Pack Number CDS983523F ; 59) C-SECTION CDS , Pack Number CDS983523G ; 60) C-SECTION CDS-LF, Pack Number CDS983869I ; 61) C-SECTION-LF, Pack Number CDS983869J ; 62) C-SECTION CDS , Pack Number CDS983897G ; 63) C-SECTION CDS , Pack Number CDS983897I ; 64) C-SECTION CDS , Pack Number CDS983934I ; 65) C-SECTION CDS , Pack Number CDS983998C ; 66) C-SECTION DELIVERY CDS, Pack Number CDS984018; 67) C-SECTION DELIVERY CDS, Pack Number CDS984018A ; 68) C-SECTION CDS , Pack Number CDS984554B ; 69) C SECTION CDS , Pack Number CDS984616A ; 70) C-SECTION CDS , Pack Number CDS984768D ; 71) C-SECTION CDS , Pack Number CDS984768F ; 72) C-SECTION , Pack Number CDS984902G ; 73) C-SECTION , Pack Number CDS984902I ; 74) C-SECTION , Pack Number CDS984902J ; 75) C-SECTION , Pack Number CDS984902K ; 76) C-SECTION CDS , Pack Number CDS985206B ; 77) C-SECTION CDS , Pack Number CDS985257G ; 78) C-SECTION CDS , Pack Number CDS985257I ; 79) C-SECTION CDS , Pack Number CDS985257J ; 80) C-SECTION CDS , Pack Number CDS985257L ; 81) C SECTION , Pack Number CDS985505G ; 82) C-SECTION , Pack Number CDS985560N ; 83) C-SECTION SET-UP PACK , Pack Number CDSOBL122F ; 84) C-SECTION SET-UP PACK , Pack Number CDSOBL122G ; 85) C-SECTION SET-UP PACK , Pack Number CD

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
AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19TBB002 ; AM160B , Lot Number 19IBN286 ; AM160B , Lot Number 19KBF062 ; AM160C , Lot Number 21FBM171 ; AM160C , Lot Number 20ABB878 ; AM160C , Lot Number 20BBW406 ; AM160C , Lot Number 20CBA975 ; AM160C , Lot Number 20DBD025 ; AM160C , Lot Number 20GBG950 ; AM160C , Lot Number 20HBV795 ; AM160C , Lot Number 21BBF298 ; AM160C , Lot Number 21BBF425 ; CDS820031I , Lot Number 19BBK847 ; CDS820031I , Lot Number 19CBE063 ; CDS820031J , Lot Number 21FBL439 ; CDS820031J , Lot Number 21GBE677 ; CDS820031J , Lot Number 21JBF745 ; CDS820031J , Lot Number 21JBN716 ; CDS820031J , Lot Number 21JBY908 ; CDS820031J , Lot Number 21KBP597 ; CDS820031J , Lot Number 21WBA979 ; CDS820031J , Lot Number 19DBM904 ; CDS820031J , Lot Number 19EBM237 ; CDS820031J , Lot Number 19FBO038 ; CDS820031J , Lot Number 19GBF747 ; CDS820031J , Lot Number 22IBI048 ; CDS820031J , Lot Number 22KBF508 ; CDS820031J , Lot Number 22KBN688 ; CDS820031J , Lot Number 19JBC701 ; CDS820031J , Lot Number 19JBU877 ; CDS820031J , Lot Number 23ABE785 ; CDS820031J , Lot Number 19JBZ086 ; CDS820031J , Lot Number 23BBR695 ; CDS820031J , Lot Number 20BBK590 ; CDS820031J , Lot Number 20BBS508 ; CDS820031J , Lot Number 20BBZ094 ; CDS820031J , Lot Number 23IBH234 ; CDS820031J , Lot Number 20FBA127 ; CDS820031J , Lot Number 23JBD093 ; CDS820031J , Lot Number 23JBW122 ; CDS820031J , Lot Number 20GBK469 ; CDS820031J , Lot Number 23LBF496 ; CDS820031J , Lot Number 20IBD516 ; CDS820031J , Lot Number 24ABA511 ; CDS820031J , Lot Number 20IBO694 ; CDS820031J , Lot Number 24BBA399 ; CDS820031J , Lot Number 24CBJ244 ; CDS820031J , Lot Number 20WBA829 ; CDS820031J , Lot Number 21ABO446 ; CDS820031J , Lot Number 21CBD958 ; CDS820081K , Lot Number 19AKA693 ; CDS820081K , Lot Number 19AKC737 ; CDS820081K , Lot Number 19CKD083 ; CDS820081K , Lot Number 19EKC898 ; CDS820081K , Lot Number 19GKB790 ; CDS820081K , Lot Number 19IKB089 ; CDS820081L , Lot Number 21GBM225 ; CDS820081L , Lot Number 21JBT012 ; CDS820081L , Lot Number 21KBK329 ; CDS820081L , Lot Number 21LBV275 ; CDS820081L , Lot Number 22BBJ584 ; CDS820081L , Lot Number 22CBP343 ; CDS820081L , Lot Number 22OBE864 ; CDS820081L , Lot Number 22IBA261 ; CDS820081L , Lot Number 22IBA535 ; CDS820081L , Lot Number 22IBF598 ; CDS820081L , Lot Number 22IBF818 ; CDS820081L , Lot Number 22LBJ357 ; CDS820081L , Lot Number 23BBO837 ; CDS820081L , Lot Number 23DBD629 ; CDS820081L , Lot Number 23FBL414 ; CDS820081L , Lot Number 23IBE629 ; CDS820081L , Lot Number 23JBM618 ; CDS820081L , Lot Number 23LBV769 ; CDS820081L , Lot Number 21EBH607 ; CDS820081L , Lot Number 19JKB104 ; CDS820081L , Lot Number 20BKA197 ; CDS820081L , Lot Number 20EKA149 ; CDS820081L , Lot Number 20EKB971 ; CDS820081L , Lot Number 20HKA772 ; CDS820081L , Lot Number 20JKA732 ; CDS820081L , Lot Number 21AKA513 ; CDS820081L , Lot Number 21BKA781 ; CDS820081L , Lot Number 21DKA368 ; CDS820103J , Lot Number 19ABL764 ; CDS820103J , Lot Number 19BBS005 ; CDS820103J , Lot Number 19EBV111 ; CDS820103J , Lot Number 19EBY378 ; CDS820103J , Lot Number 19JBS022 ; CDS820103J , Lot Number 20ABB891 ; CDS820103K , Lot Number 21GBS686 ; CDS820103K , Lot Number 21HBO942 ; CDS820103K , Lot Number 21IBU509 ; CDS820103K , Lot Number 21KBH180 ; CDS820103K , Lot Number 22FBD651 ; CDS820103K , Lot Number 22IBQ907 ; CDS820103K , Lot Number 22KBF406 ; CDS820103K , Lot Number 20BBU842 ; CDS820103K , Lot Number 20DBL326 ; CDS820103K , Lot Number 20FBC135 ; CDS820103K , Lot Number 21DBU800 ; CDS820103K , Lot Number 21FBC708 ; CDS820116F , Lot Number 22FBT978 ; CDS820116F , Lot Number 22HBF998 ; CDS820116F , Lot Number 22HBG001 ; CDS820116F , Lot Number 23DBE676 ; CDS820116G , Lot Number 23FBA021 ; CDS820116G , Lot Number 23GBJ388 ; CDS820116G , Lot Number 23GBN367 ; CDS820116G , Lot Number 23HB
Risk classification
Class II
Area (FDA)
device
Country
United States

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