FDA Device Recalls

Recalls / —

—#208131

Product

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

FDA product code
OEZ — Cardiovascular Procedure Kit
Device class
Class 2
Medical specialty
Cardiovascular
Affected lot / code info
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

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Recalling firm

Firm
MEDLINE INDUSTRIES, LP Northfield
Address
3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern
Worldwide

Timeline

Recall initiated
2024-04-08
Posted by FDA
2024-08-28
Status
—

Source: openFDA Device Recall endpoint. Recall record ID #208131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.