Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; ...
FDA Device Recall #Z-2751-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-2751-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
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
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 Pattern
Worldwide
Lot / Code Information
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 ;
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.