Class II FDA device recall · Z-2743-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2743-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2024-04-08

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2743-2024 · Source: openFDA enforcement.