medical Class II Updated 2024-09-04

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW

Recalled Product

Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number ACC010641 ; 6) NEONATAL DRAWER 6 , Pack Number ACC010653 ; 7) DRAWER 2, Pack Number ACC010690 ; 8) ****, Pack Number ACC010690 ; 9) DRAWER 3, Pack Number ACC010784 ; 10) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 11) CIRCUMCISION KIT, Pack Number CIT6535; 12) CIRCUMCISION TRAY, Pack Number CIT6720; 13) CIRCUMCISION TRAY, Pack Number CIT6720A; 14) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 17) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 18) RETINA LAC/USC PACK , Pack Number CMPJ03205D; 19) AAA PACK-LF, Pack Number CMPJ09869B; 20) ****, Pack Number CMPJ21114P; 21) BRONCHOSCOPY KIT, Pack Number DYKE1764; 22) TRUNK KIT W/OUT EXPIRATION, Pack Number DYKM1360A ; 23) PRE OP KIT, Pack Number DYKS1256B ; 24) CIRCUMCISION TRAY, Pack Number DYNDA2271; 25) DMEK KIT, Pack Number DYNDA3103 ; 26) KIT, NICU - PICU , Pack Number DYNDL1576 ; 27) BASIC EYE PACK-LF , Pack Number DYNJ0413783N ; 28) VASCULAR PACK, Pack Number DYNJ34240I; 29) VASCULAR PACK-LF, Pack Number DYNJ52214 ; 30) SONDHEIMER, Pack Number DYNJ53853C; 31) BUCKLE PACK, Pack Number DYNJ57439A; 32) RETINA CUSTOM PACK, Pack Number DYNJ57970A; 33) AESC PHACO PACK, Pack Number DYNJ58135C; 34) PED RIGHT LEFT HEART PK MHS , Pack Number DYNJ58874 ; 35) PEDIATRIC RIGHT HEART PK MHS, Pack Number DYNJ58875 ; 36) CV MAJOR, Pack Number DYNJ64530 ; 37) ORL BRONCHOSCOPY PACK, Pack Number DYNJ80103A; 38) ISLET CELL , Pack Number DYNJ80490 ; 39) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179 ; 40) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179H; 41) ACCESSORY KIT, Pack Number DYNJ901348D; 42) AAA, Pack Number DYNJ905651B; 43) PROCEDURE TRAY , Pack Number DYNJRA0345F; 44) PROCEDURE TRAY , Pack Number DYNJRA1250B; 45) PROCEDURE TRAY , Pack Number DYNJRA1777; 46) BLOCK TRAY, Pack Number DYNJRA2352; 47) ADULT CORONARY PACK , Pack Number DYNJV0275O; 48) ****, Pack Number DYNJV0275O; 49) NURSING KIT, Pack Number EDUC05026 ; 50) RNSG 2308 , Pack Number EDUC1031; 51) RNSG 2308 , Pack Number EDUC1031H ; 52) RNSG 2201 , Pack Number EDUC1034; 53) RNSG 2201 , Pack Number EDUC1034H ; 54) RETINAL INJECTION KIT, Pack Number MNS12465; 55) ARTHROGRAPH TRAY, Pack Number MNS12670A; 56) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 57) PERIPHERAL ULTRASOUND CATHETER, Pack Number MNS9865 ; 58) UVT KIT , Pack Number PAIN1396; 59) SHUNT PACK-LF, Pack Number PHS967363W; 60) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 61) GLMI ARTHROGRAM KIT , Pack Number SPEC0300B ; 62) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190B; 63) UMBILICAL TRAY , Pack Number UVT1195 ; 64) UVT KIT , Pack Number UVT1200 ; 65) UVT KIT , Pack Number UVT1200H; 66) UMBILICAL CATH KIT, Pack Number UVT1210 ; 67) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT150; 68) UMBILICAL VESSEL CATHETER TRAY, Pack Number UVT665A ; 69) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT915


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: ACC010417, Lot Numbers: 21JDC136; ACC010417, Lot Numbers: 21LDA261; ACC010417, Lot Numbers: 22BDA205; ACC010417, Lot Numbers: 22FDB645; ACC010417A , Lot Numbers: 23GDA903; ACC010417A , Lot Numbers: 23HDA001; ACC010417A , Lot Numbers: 23HDB495; ACC010417A , Lot Numbers: 23IDA233; ACC010417A , Lot Numbers: 23IDB522; ACC010417A , Lot Numbers: 23JDB187; ACC010427A , Lot Numbers: 23EDA979; ACC010427A , Lot Numbers: 23IDB947; ACC010605, Lot Numbers: 22LDB120; ACC010605, Lot Numbers: 23ADB200; ACC010605, Lot Numbers: 23ADB656; ACC010605, Lot Numbers: 23BDA934; ACC010641, Lot Numbers: 23GDC055; ACC010653, Lot Numbers: 23HDC266; ACC010690, Lot Numbers: 23IDA111; ACC010690, Lot Numbers: 23IDB053; ACC010690, Lot Numbers: 24CDB296; ACC010784, Lot Numbers: 24CDA251; CIT4845, Lot Numbers: 2022070190; CIT6535, Lot Numbers: 2023122680; CIT6720, Lot Numbers: 2022050290; CIT6720, Lot Numbers: 2023052690; CIT6720A, Lot Numbers: 2023111090; CIT6780, Lot Numbers: 2023052690; CIT6920, Lot Numbers: 2022030890; CIT6925, Lot Numbers: 2022051690; CIT6925, Lot Numbers: 2022101090; CIT6925, Lot Numbers: 2023062690; CIT7095, Lot Numbers: 2022071390; CMPJ03205D , Lot Numbers: 24BBI377; CMPJ09869B , Lot Numbers: 23HMH649; CMPJ09869B , Lot Numbers: 23KMB759; CMPJ09869B , Lot Numbers: 24AME944; CMPJ21114P , Lot Numbers: 24CBJ402; DYKE1764 , Lot Numbers: 22FBS049; DYKE1764 , Lot Numbers: 23ABO112; DYKE1764 , Lot Numbers: 23CBR915; DYKE1764 , Lot Numbers: 23IBF012; DYKM1360A, Lot Numbers: 23FBT211; DYKS1256B, Lot Numbers: 21CBR391; DYKS1256B, Lot Numbers: 21DBV160; DYKS1256B, Lot Numbers: 21HMG454; DYKS1256B, Lot Numbers: 22AMG240; DYKS1256B, Lot Numbers: 22DMF530; DYKS1256B, Lot Numbers: 23CMD114; DYKS1256B, Lot Numbers: 23GMA886; DYKS1256B, Lot Numbers: 23HMH613; DYNDA2271, Lot Numbers: 2022070190; DYNDA3103, Lot Numbers: 24BBA889; DYNDL1576, Lot Numbers: 23DBF325; DYNDL1576, Lot Numbers: 23FBF144; DYNDL1576, Lot Numbers: 24ABO204; DYNDL1576, Lot Numbers: 24BBO954; DYNJ0413783N, Lot Numbers: 23IMC236; DYNJ0413783N, Lot Numbers: 23JMB485; DYNJ34240I , Lot Numbers: 21KBQ916; DYNJ34240I , Lot Numbers: 21KBQ921; DYNJ34240I , Lot Numbers: 22FBJ330; DYNJ34240I , Lot Numbers: 22JBN374; DYNJ34240I , Lot Numbers: 23JMI380; DYNJ34240I , Lot Numbers: 23KME465; DYNJ34240I , Lot Numbers: 23LMB750; DYNJ52214, Lot Numbers: 22GBM584; DYNJ52214, Lot Numbers: 23EBV426; DYNJ52214, Lot Numbers: 23FBQ525; DYNJ52214, Lot Numbers: 23LBO633; DYNJ52214, Lot Numbers: 24BBJ934; DYNJ52214, Lot Numbers: 24BBT876; DYNJ52214, Lot Numbers: 20LBO359; DYNJ53853C , Lot Numbers: 21FMA744; DYNJ53853C , Lot Numbers: 21FMB832; DYNJ53853C , Lot Numbers: 22BMG093; DYNJ53853C , Lot Numbers: 22IMG468; DYNJ57439A , Lot Numbers: 21KBR361; DYNJ57439A , Lot Numbers: 22JBF797; DYNJ57439A , Lot Numbers: 22KBK481; DYNJ57970A , Lot Numbers: 21FBT988; DYNJ58135C , Lot Numbers: 23EBB779; DYNJ58135C , Lot Numbers: 23FBD603; DYNJ58135C , Lot Numbers: 23FBT783; DYNJ58135C , Lot Numbers: 23JBT096; DYNJ58135C , Lot Numbers: 21BMA342; DYNJ58135C , Lot Numbers: 21CMC960; DYNJ58135C , Lot Numbers: 21EMA605; DYNJ58135C , Lot Numbers: 21FMA438; DYNJ58135C , Lot Numbers: 21GMD933; DYNJ58135C , Lot Numbers: 22AMF725; DYNJ58874, Lot Numbers: 22EBP939; DYNJ58874, Lot Numbers: 23FBR955; DYNJ58874, Lot Numbers: 23FBT080; DYNJ58875, Lot Numbers: 23FBM015; DYNJ58875, Lot Numbers: 23GBD061; DYNJ58875, Lot Numbers: 23JBW886; DYNJ64530, Lot Numbers: 23IBS196; DYNJ80103A , Lot Numbers: 23HBN888; DYNJ80103A , Lot Numbers: 23IBE224; DYNJ80490, Lot Numbers: 22FDB938; DYNJ82179, Lot Numbers: 23IDB760; DYNJ82179H , Lot Numbers: 23IDB760; DYNJ901348D , Lot Numbers: 22CBN435; DYNJ901348D , Lot Numbers: 22GBN021; DYNJ901348D , Lot Numbers: 22IBL110; DYNJ901348D , Lot Numbers: 22JBO112; DYNJ901348D , Lot Numbers: 23CBJ265; DYNJ901348D , Lot Numbers: 23DBG454; DYNJ901348D , Lot Numbers: 23HBJ345; DYNJ901348D , Lot Numbers: 23IBV193; DYNJ901348D , Lot Numbers: 23JBU781; DYNJ905651B , Lot Numbers: 23IMH419; DYNJ905651B , Lot Numbers: 23LMG546; DYNJ905651B , Lot Numbers: 24BME750; DYNJRA0345F , Lot Numbers: 23ABR895; DYNJRA1250B , Lot Numbers: 22EBF982; DYNJRA1250B , Lot Numbers: 23FMC743; DYNJRA1250B , Lot Numbers: 23FMF948; DYNJRA1250B , Lot Numbers: 23JMG164; DYNJRA1777 , Lot Numbers: 23CBE622; DYNJRA2352 , Lot Numbers: 24BBJ316; DYNJV0275O , Lot Numbers: 24AMH648; DYNJV0275O , Lot Numbers: 24CME159; EDUC05026, Lot Numbers: 21HDB123; EDUC05026, Lot Numbers: 21HDC026; EDUC05026, Lot Numbers: 21IDB633; EDUC05026, Lot Numbers: 21JDB157; EDUC05026, Lot Numbers: 21KDB162; EDUC05026, Lot Numbers: 21LDA686; EDUC05026, Lot Numbers: 22ADA717; EDUC05026, Lot Numbers: 22BDB179; EDUC05026, Lot Numbers: 22DDA921; EDUC1031 , Lot Numbers: 23BLA800; EDUC1031H, Lot Numbers: 23BLA800; EDUC1034 , Lot Numbers: 23CLA376; EDUC1034H, Lot Numbers: 23CLA376; MNS12465, Lot Numbers: 2022081990; MNS12670A, Lot Numbers: 2022050290; MNS9865, Lot Numbers: 2022051050; MNS9865 , Lot Numbers: 23EMI898; PAIN1396 , Lot Numbers: 22FBN139; PHS967363W , Lot Numbers: 23JMB678; SPEC0300B, Lot Numbers: 2021090750; SPEC0300B, Lot Numbers: 2022051050; SPEC0300B, Lot Numbers: 23JBD693; SPEC0300B, Lot Numbers: 23KBH304; SPEC0300B, Lot Numbers: 24ABS449; UVT1190B , Lot Numbers: 24ABS540; UVT1195 , Lot Numbers: 22FBN138; UVT1200 , Lot Numbers: 22FBN139; UVT1200H , Lot Numbers: 22FBN139; UVT1210 , Lot Numbers: 22GBH327; UVT1210 , Lot Numbers: 22JBT476; UVT1210 , Lot Numbers: 22JBU369; UVT1210 , Lot Numbers: 23FBB299; UVT1210 , Lot Numbers: 23GBA743; UVT1210 , Lot Numbers: 23JBK029; UVT1210 , Lot Numbers: 23LBM731; UVT150, Lot Numbers: 22FBX796; UVT150, Lot Numbers: 22HBN579; UVT150, Lot Numbers: 22JBI343; UVT150, Lot Numbers: 22JBN119; UVT150, Lot Numbers: 23BBJ954; UVT150, Lot Numbers: 23EBS525; UVT150, Lot Numbers: 23GBD813; UVT150, Lot Numbers: 23GBR233; UVT150, Lot Numbers: 23IBS687; UVT150, Lot Numbers: 23JBY235; UVT665A , Lot Numbers: 22FBK838; UVT665A , Lot Numbers: 22IBV837; UVT665A , Lot Numbers: 22KBQ011; UVT665A , Lot Numbers: 23GBD803; UVT665A , Lot Numbers: 23IBI160; UVT915, Lot Numbers: 23CBN895; UVT915, Lot Numbers: 23JBY224 ;
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