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Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEAR...

FDA Device Recall #Z-2743-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-2743-2024
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) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack Number CDS984206R; 7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P; 8) OPEN HEART A&B PACK, Pack Number CMPJ02162I; 9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J; 10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C; 11) VASCULAR PACK, Pack Number CMPJ08949F; 12) BOISE HEART PACK-LF, Pack Number CMPJ09225F; 13) VASCULAR PACK, Pack Number CMPJ09236D; 14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F; 15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C; 16) CAROTID PACK, Pack Number CMPJ10797B; 17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A; 18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B; 19) VASCULAR PACK, Pack Number CMPJ13632; 20) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048M; 21) CABG PACK-LF, Pack Number DYNJ0824648K; 22) HEART PEDIATRIC PACK-LF, Pack Number DYNJ16541R; 23) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 24) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 25) PEDIATRIC CARDIO CATH PACK, Pack Number DYNJ35578G; 26) MAJOR VASCULAR PACK, Pack Number DYNJ38318F; 27) MAJOR VASCULAR PACK, Pack Number DYNJ38318G; 28) EP PACER PACK, Pack Number DYNJ38863N; 29) EP PACER PACK, Pack Number DYNJ38863O; 30) PERFUSION SYRINGE, Pack Number DYNJ39223C; 31) VASCULAR PACK, Pack Number DYNJ39525; 32) VASCULAR ADD ON PACK, Pack Number DYNJ44420C; 33) SHUNT ENDARTERECTOMY, Pack Number DYNJ44565D; 34) VASCULAR ACCESS PACK, Pack Number DYNJ56510A; 35) HEART VALVE PACK, Pack Number DYNJ58365J; 36) RIGHT HEART PACK MOSES, Pack Number DYNJ58873A; 37) GENERAL VASCULAR PACK, Pack Number DYNJ60177A; 38) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904A; 39) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904B; 40) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904C; 41) PK, VASCULAR-MAJOR, Pack Number DYNJ61603A; 42) VASCULAR PACK, Pack Number DYNJ63182A; 43) VASCULAR SHARED, Pack Number DYNJ64801B; 44) VASCULAR PACK, Pack Number DYNJ65160; 45) VASCULAR DSC, Pack Number DYNJ69172B; 46) OPEN HEART PACK, Pack Number DYNJ83695; 47) WMC HYBRID OR, Pack Number DYNJ904036J; 48) VASCULAR, Pack Number DYNJ904845G; 49) BOISE HEART, Pack Number DYNJ905070I; 50) VASCULAR/OR ANGIO, Pack Number DYNJ905079F; 51) VASCULAR PACK, Pack Number DYNJ905226D; 52) CAROTID, Pack Number DYNJ906561F; 53) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744A; 54) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744B; 55) UNIVERSITY VASCULAR, Pack Number DYNJ907201B; 56) KIT OPEN HEART, Pack Number DYNJ908603B; 57) VASCULAR PACK, Pack Number DYNJ909374; 58) ISLET CELL UNIV OF IL, Pack Number DYNJ909768; 59) ADULT CORONARY PACK, Pack Number DYNJV0275J; 60) ADULT CORONARY PACK, Pack Number DYNJV0275K; 61) ADULT CORONARY PACK, Pack Number DYNJV0275M; 62) ADULT CORONARY PACK, Pack Number DYNJV0275N

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

CDS981050Q , Lot Numbers : 23IBJ172 ; CDS982411N , Lot Numbers : 23IBH624 ; CDS982411N , Lot Numbers : 23IBI963 ; CDS983348AA, Lot Numbers : 23FBN637 ; CDS983348AA, Lot Numbers : 24ABM288 ; CDS983348AA, Lot Numbers : 24ABR888 ; CDS983348X , Lot Numbers : 22GBA977 ; CDS983348X , Lot Numbers : 22KBB264 ; CDS983348Y , Lot Numbers : 23BBR849 ; CDS983348Y , Lot Numbers : 23CBM949 ; CDS983348Y , Lot Numbers : 23DBB694 ; CDS984206R , Lot Numbers : 22GBP993 ; CDS984206R , Lot Numbers : 22HBU408 ; CDS984206R , Lot Numbers : 22KLA374 ; CDS984206R , Lot Numbers : 22KLB170 ; CDS984206R , Lot Numbers : 22LLA600 ; CDS984206R , Lot Numbers : 23ALA250 ; CDS984206R , Lot Numbers : 23ALA462 ; CDS984206R , Lot Numbers : 23ALA777 ; CDS984206R , Lot Numbers : 23BLA402 ; CMPJ01037P , Lot Numbers : 23HBT114 ; CMPJ02162I , Lot Numbers : 23HBT075 ; CMPJ03510J , Lot Numbers : 22GBD932 ; CMPJ03510J , Lot Numbers : 22GBK674 ; CMPJ03510J , Lot Numbers : 22JLA999 ; CMPJ03510J , Lot Numbers : 22KLA443 ; CMPJ03510J , Lot Numbers : 22LLA230 ; CMPJ03510J , Lot Numbers : 22LLA577 ; CMPJ03510J , Lot Numbers : 23ALA797 ; CMPJ06631C , Lot Numbers : 23HBQ375 ; CMPJ06631C , Lot Numbers : 23HBU697 ; CMPJ08949F , Lot Numbers : 23HBT997 ; CMPJ09225F , Lot Numbers : 23HBP652 ; CMPJ09236D , Lot Numbers : 22GBG807 ; CMPJ09236F , Lot Numbers : 22HBN769 ; CMPJ09236F , Lot Numbers : 22HBY712 ; CMPJ09236F , Lot Numbers : 23FBF790 ; CMPJ09236F , Lot Numbers : 23FBM695 ; CMPJ09400C , Lot Numbers : 23HBZ030 ; CMPJ10797B , Lot Numbers : 23JMD630 ; CMPJ10797B , Lot Numbers : 23KMC572 ; CMPJ10985A , Lot Numbers : 22FBL206 ; CMPJ10985A , Lot Numbers : 22GBI791 ; CMPJ10985B , Lot Numbers : 23FBK179 ; CMPJ10985B , Lot Numbers : 23GBV588 ; CMPJ10985B , Lot Numbers : 23HBM747 ; CMPJ10985B , Lot Numbers : 23LBA858 ; CMPJ13632, Lot Numbers : 23BMH813 ; CMPJ13632, Lot Numbers : 23GMC952 ; DYNJ0382048M , Lot Numbers : 23IBB114 ; DYNJ0824648K , Lot Numbers : 24AMF586 ; DYNJ16541R , Lot Numbers : 21HMA102 ; DYNJ16541R , Lot Numbers : 21IMA181 ; DYNJ35495G , Lot Numbers : 21EMF046 ; DYNJ35495G , Lot Numbers : 22AMD743 ; DYNJ35495G , Lot Numbers : 22EMD093 ; DYNJ35495G , Lot Numbers : 22FMF078 ; DYNJ35495G , Lot Numbers : 22GMC660 ; DYNJ35495G , Lot Numbers : 22HMF027 ; DYNJ35495G , Lot Numbers : 22IMC912 ; DYNJ35495G , Lot Numbers : 22JMA533 ; DYNJ35495G , Lot Numbers : 22JMD015 ; DYNJ35495G , Lot Numbers : 23DMH903 ; DYNJ35495G , Lot Numbers : 23EME329 ; DYNJ35495G , Lot Numbers : 24AMF976 ; DYNJ35495G , Lot Numbers : 24CME720 ; DYNJ35578G , Lot Numbers : 21IMA037 ; DYNJ35578G , Lot Numbers : 22HMA397 ; DYNJ35578G , Lot Numbers : 22IMF130 ; DYNJ35578G , Lot Numbers : 22JMA828 ; DYNJ38318F , Lot Numbers : 21GME196 ; DYNJ38318F , Lot Numbers : 22CME760 ; DYNJ38318F , Lot Numbers : 22DMD733 ; DYNJ38318G , Lot Numbers : 23CMH527 ; DYNJ38318G , Lot Numbers : 23FMI730 ; DYNJ38318G , Lot Numbers : 23GMH025 ; DYNJ38318G , Lot Numbers : 23KMF993 ; DYNJ38863N , Lot Numbers : 21JBD563 ; DYNJ38863N , Lot Numbers : 21KBU816 ; DYNJ38863N , Lot Numbers : 22GBL827 ; DYNJ38863N , Lot Numbers : 22HBO261 ; DYNJ38863O , Lot Numbers : 22JBX664 ; DYNJ38863O , Lot Numbers : 23JBU100 ; DYNJ39223C , Lot Numbers : 23JMH881 ; DYNJ39525, Lot Numbers : 23HBO406 ; DYNJ44420C , Lot Numbers : 21DMB030 ; DYNJ44420C , Lot Numbers : 21IMG926 ; DYNJ44420C , Lot Numbers : 22AMB411 ; DYNJ44420C , Lot Numbers : 23FMA481 ; DYNJ44420C , Lot Numbers : 23KME889 ; DYNJ44565D , Lot Numbers : 23IBD702 ; DYNJ56510A , Lot Numbers : 23IBE173 ; DYNJ58365J , Lot Numbers : 22BMF809 ; DYNJ58365J , Lot Numbers : 22CMA087 ; DYNJ58365J , Lot Numbers : 22CMF024 ; DYNJ58365J , Lot Numbers : 22DME619 ; DYNJ58365J , Lot Numbers : 22KMF019 ; DYNJ58365J , Lot Numbers : 22LMA757 ; DYNJ58365J , Lot Numbers : 23AMI644 ; DYNJ58873A , Lot Numbers : 23HBO872 ; DYNJ60177A , Lot Numbers : 22GBZ669 ; DYNJ60904A , Lot Numbers : 23CBL795 ; DYNJ60904A , Lot Numbers : 23DBQ189 ; DYNJ60904A , Lot Numbers : 23GBG492 ; DYNJ60904A , Lot Numbers : 21CMD975 ; DYNJ60904A , Lot Numbers : 21FMC958 ; DYNJ60904A , Lot Numbers : 21HME949 ; DYNJ60904A , Lot Numbers : 21LMG891 ; DYNJ60904B , Lot Numbers : 23IBR916 ; DYNJ60904B , Lot Numbers : 23JBO985 ; DYNJ60904C , Lot Numbers : 24BBT698 ; DYNJ60904C , Lot Numbers : 24CBD151 ; DYNJ61603A , Lot Numbers : 23IDB820 ; DYNJ63182A , Lot Numbers : 23IBB016 ; DYNJ64801B , Lot Numbers : 23JDA487 ; DYNJ65160, Lot Numbers : 21GDC784 ; DYNJ65160, Lot Numbers : 21HDA957 ; DYNJ65160, Lot Numbers : 21HDC449 ; DYNJ65160, Lot Numbers : 22CDA586 ; DYNJ65160, Lot Numbers : 22CDB328 ; DYNJ65160, Lot Numbers : 23HDA374 ; DYNJ69172B , Lot Numbers : 23KMC637 ; DYNJ83695, Lot Numbers : 23KMC043 ; DYNJ904036J, Lot Numbers : 23GBO515Z; DYNJ904845G, Lot Numbers : 23IBO715 ; DYNJ905070I, Lot Numbers : 23IBL120 ; DYNJ905079F, Lot Numbers : 22IBS192 ; DYNJ905079F, Lot Numbers : 23GBV464 ; DYNJ905226D, Lot Numbers : 23IBT451 ; DYNJ906561F, Lot Numbers : 23KMD566 ; DYNJ906561F, Lot Numbers : 23LMC047 ; DYNJ906744A, Lot Numbers : 22HBA285 ; DYNJ906744A, Lot Numbers : 22HBS673 ; DYNJ906744A, Lot Numbers : 22JBC173 ; DYNJ906744B, Lot Numbers : 23GBB637 ; DYNJ906744B, Lot Numbers : 23HBL689 ; DYNJ906744B, Lot Numbers : 23LBJ453 ; DYNJ907201B, Lot Numbers : 23IBQ651 ; DYNJ907201B, Lot Numbers : 23IBR482 ; DYNJ908603B, Lot Numbers : 23DLA943 ; DYNJ908603B, Lot Numbers : 23ELA182 ; DYNJ908603B, Lot Numbers : 23ILA483 ; DYNJ908603B, Lot Numbers : 23JLA399 ; DYNJ908603B, Lot Numbers : 23JLA761 ; DYNJ908603B, Lot Numbers : 23LLA530 ; DYNJ908603B, Lot Numbers : 24ALA353 ; DYNJ909374 , Lot Numbers : 23CMF350 ; DYNJ909374 , Lot Numbers : 23GMH651 ; DYNJ909768 , Lot Numbers : 23KDA010 ; DYNJ909768 , Lot Numbers : 23KDB476 ; DYNJV0275J , Lot Numbers : 20JMD542 ; DYNJV0275K , Lot Numbers : 21FMB371 ; DYNJV0275M , Lot Numbers : 22BMG807 ; DYNJV0275M , Lot Numbers : 22CMD978 ; DYNJV0275M , Lot Numbers : 22DMB068 ; DYNJV0275M , Lot Numbers : 22DME051 ; DYNJV0275M , Lot Numbers : 22DMH576 ; DYNJV0275M , Lot Numbers : 22EME738 ; DYNJV0275M , Lot Numbers : 22GMB674 ; DYNJV0275M , Lot Numbers : 22KMA130 ; DYNJV0275N , Lot Numbers : 23JMH200 ; DYNJV0275N , Lot Numbers : 23LMA628

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.

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