Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW &
Summary
The FDA issued a Class II for Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Num by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-2751-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
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
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 ;
Reason for Recall
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.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2751-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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