FDAFDA · Food and drugs·Recall number Z-3054-2024

Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 40) ARTHROGRAM TRAY , Pack Number DYNDH1134; 41) ARTHROGRAM TRAY , Pack Number DYNDH1243; 42) ARTHROGRAM PACK , Pack Number DYNDH1322; 43) ARTHROGRAM TRAY , Pack Number DYNDH1347; 44) ARTHROGRAM TRAY , Pack Number DYNDH1349; 45) ARTHROGRAM PACK , Pack Number DYNDH1350; 46) BEACH CHAIR SHOULDER PACK-LF, Pack Number DYNJ00040K ; 47) ARTHROGRAM PACK-LF, Pack Number DYNJ0101275A ; 48) ARTHROSCOPY PACK-LF , Pack Number DYNJ0101722C ; 49) ARTHROSCOPY PACK-LF , Pack Number DYNJ0103045G ; 50) ARTHROSCOPY LV - EDOC PACK-LF , Pack Number DYNJ0111409L ; 51) ARTHROSCOPY PACK-LF , Pack Number DYNJ01114D ; 52) ARTHROSCOPY II PACK-LF, Pack Number DYNJ0161097B ; 53) ARTHROSCOPY PACK, Pack Number DYNJ01829F ; 54) ARTHROSCOPY PACK-LF , Pack Number DYNJ0190768L ; 55) ARTHROSCOPY PACK-LF , Pack Number DYNJ0200295Q ; 56) ARTHROSCOPY PACK-LF , Pack Number DYNJ0219853Q ; 57) YUMH/SURGI-CENTER ARTHRO PK-LF, Pack Number DYNJ0244761K ; 58) ARTHRO KNEE PACK, Pack Number DYNJ02579F ; 59) ARTHROSCOPY PACK-LF , Pack Number DYNJ0281409O ; 60) PPSC ARTHROSCOPY PACK-LF, Pack Number DYNJ0303231D ; 61) ARTHROSCOPY PACK-LF , Pack Number DYNJ0365867L ; 62) ARTHROSCOPY PACK-LF , Pack Number DYNJ0366488I ; 63) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373216K ; 64) ARTHROSCOPY PACK-LF , Pack Number DYNJ0373876F ; 65) ARTHROSCOPY PACK-LF , Pack Number DYNJ0374577N ; 66) ARTHROSCOPY PACK-LF , Pack Number DYNJ0376528J ; 67) ARTHROSCOPY PACK-LF , Pack Number DYNJ0377096D ; 68) ARTHROSCOPY PACK-LF , Pack Number DYNJ0378266K ; 69) ARTHROSCOPY PACK-LF , Pack Number DYNJ0382618L ; 70) ARTHROSCOPY PACK-LF , Pack Number DYNJ0390808F ; 71) ARTHROSCOPY PACK-LF , Pack Number DYNJ0399877G ; 72) ARTHROSCOPY PACK-LF , Pack Number DYNJ0406086L ; 73) ARTHROSCOPY PACK-LF , Pack Number DYNJ0410034P ; 74) GYN RESECTOSCOPE PACK-LF, Pack Number DYNJ0415339I ; 75) ARTHROSCOPY PROCEDURE PACK-LF , Pack Number DYNJ0415915I ; 76) ARTHROSCOPY PACK, Pack Number DYNJ04159A ; 77) ARTHROSCOPY PACK-LF , Pa

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: 00-399027M , Lot Number 19GLA310 ; 00-399027M , Lot Number 19KLA520 ; 00-399027M , Lot Number 19LLA487 ; 00-399027M , Lot Number 20LLA663 ; 00-399027M , Lot Number 21JLA024 ; 00-399027M , Lot Number 21KLA330 ; 00-399027M , Lot Number 22GLA379 ; 00-399027M , Lot Number 22HLA991 ; 00-399027M , Lot Number 23FLA497 ; 00-399027M , Lot Number 23GLA579 ; CDS940242I , Lot Number 19BBK957 ; CDS940242I , Lot Number 19KBO521 ; CDS940242I , Lot Number 20ABP687 ; CDS940242I , Lot Number 20BBW841 ; CDS940242I , Lot Number 20EBC100 ; CDS940242I , Lot Number 20EBD870 ; CDS940242I , Lot Number 20EBI718 ; CDS940242I , Lot Number 21BBM845 ; CDS940242I , Lot Number 21DBU612 ; CDS940859J , Lot Number 19BBN781 ; CDS940859J , Lot Number 19CBI613 ; CDS940859J , Lot Number 19DBF963 ; CDS940859J , Lot Number 19FBF630 ; CDS940859J , Lot Number 19FBZ846 ; CDS940859J , Lot Number 19KBX776 ; CDS940859J , Lot Number 20ABJ911 ; CDS940859J , Lot Number 20ABX308 ; CDS940859J , Lot Number 20DBB231 ; CDS940869U , Lot Number 22JBA443 ; CDS940869U , Lot Number 22JBR468 ; CDS940869U , Lot Number 22KBM258 ; CDS940869U , Lot Number 23ABM583 ; CDS940869U , Lot Number 23EBO018 ; CDS940869U , Lot Number 23FBQ994 ; CDS940869U , Lot Number 23IBJ529 ; CDS940869U , Lot Number 23IBQ730 ; CDS940869U , Lot Number 23JBT822 ; CDS940869U , Lot Number 24ABP580 ; CDS940960I , Lot Number 19ABS109 ; CDS940960I , Lot Number 19CBJ215 ; CDS940960I , Lot Number 19DBT115 ; CDS940960I , Lot Number 19EBZ737 ; CDS940960I , Lot Number 19GBF742 ; CDS940960I , Lot Number 19IBA018 ; CDS940960I , Lot Number 19KBC364 ; CDS940960I , Lot Number 19LBW494 ; CDS940960I , Lot Number 20CBG534 ; CDS940960I , Lot Number 20FBI380 ; CDS941059L , Lot Number 19ABX775 ; CDS941059L , Lot Number 19CBL345 ; CDS941059L , Lot Number 19EBK936 ; CDS941059L , Lot Number 19HBJ184 ; CDS941059L , Lot Number 19TBD995 ; CDS941059L , Lot Number 19JBR652 ; CDS941059L , Lot Number 19KBB784 ; CDS941062K , Lot Number 22AMA714 ; CDS941062K , Lot Number 22GMD219 ; CDS941062K , Lot Number 19DKC651 ; CDS941062K , Lot Number 19FKC535 ; CDS941062K , Lot Number 19IKA405 ; CDS941062K , Lot Number 19JKC269 ; CDS941062K , Lot Number 19LKA167 ; CDS941062K , Lot Number 19LKA900 ; CDS941062K , Lot Number 20AKB960 ; CDS941062K , Lot Number 20BKA037 ; CDS941062K , Lot Number 20GKA320 ; CDS941062K , Lot Number 20KKA153 ; CDS941062K , Lot Number 21BKA656 ; CDS941062K , Lot Number 21DKA144 ; CDS941110L , Lot Number 19ABP891 ; CDS980751I , Lot Number 19ABG326 ; CDS980751I , Lot Number 19CBC069 ; CDS980751I , Lot Number 19PBC659 ; CDS980751I , Lot Number 19EBY507 ; CDS980751I , Lot Number 19JBQ823 ; CDS980893, Lot Number 21HBI057 ; CDS980893, Lot Number 21HBN843 ; CDS980893, Lot Number 19CBT746 ; CDS980893, Lot Number 19FBQ260 ; CDS980893, Lot Number 20CBU529 ; CDS980893, Lot Number 20DBH163 ; CDS980893, Lot Number 20EBD321 ; CDS980893, Lot Number 22LMH116 ; CDS980893, Lot Number 23DMI538 ; CDS981003K , Lot Number 19CBI799 ; CDS981003K , Lot Number 19DBM871 ; CDS981011B , Lot Number 19ALA437 ; CDS981011B , Lot Number 19DLA180 ; CDS981011B , Lot Number 19ELA299 ; CDS981011B , Lot Number 19HLA043 ; CDS981011B , Lot Number 19ILA116 ; CDS981011B , Lot Number 19LLA383 ; CDS981011B , Lot Number 20CLA609 ; CDS981011B , Lot Number 20DLA233 ; CDS981011B , Lot Number 20FLA487 ; CDS981011B , Lot Number 20HLA260 ; CDS981011B , Lot Number 20ILA129 ; CDS981011B , Lot Number 20JLA036 ; CDS981011B , Lot Number 21BLA152 ; CDS981011B , Lot Number 21ELA215 ; CDS981011B , Lot Number 21ILA514 ; CDS981660J , Lot Number 19ADD231 ; CDS981660J , Lot Number 19CDB082 ; CDS981660J , Lot Number 19FDA575 ; CDS981660J , Lot Number 19GDC558 ; CDS981660J , Lot Number 19JDA303 ; CDS981660J , Lot Number 19KDB911 ; CDS981660J , Lot Number 20ADC657 ; CDS982199G , Lot Number 19BBH902 ; CDS982199G , Lot Number 19BBI111 ; CDS982199G , Lot Number 19CBC678 ; CDS982216C , Lot Numbe
Risk classification: Class II
Area (FDA): device
Country: United States

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