FDAFDA · Food and drugs·Recall number Z-2627-2024

Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) no name , Pack Number DYNJ0161241F ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 56) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 62) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 68) CATH PACK-LF, Pack Number DYNJ0367643Q ; 69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ

Published September 4, 2024 · Recall initiated: April 8, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Distributor: Worldwide distribution.
Lot: 00-398281J , Lot Number 19FBL693 ; 00-398281J , Lot Number 19HBQ768 ; 00-398281J , Lot Number 19IBJ984 ; 00-398281J , Lot Number 19JBM853 ; 00-398650AG, Lot Number 19ABM946 ; 00-398650AG, Lot Number 19BBS748 ; 00-398650AG, Lot Number 19CBJ825 ; 00-398650AG, Lot Number 19DBR708 ; 00-398650AG, Lot Number 19FBR243 ; 00-398650AG, Lot Number 19IBV635 ; 00-398650AG, Lot Number 19KBL462 ; 00-398650AG, Lot Number 20MBA140 ; 00-398650AG, Lot Number 20EBE408 ; 00-398650AG, Lot Number 20FBJ771 ; 00-398650AG, Lot Number 20HBI575 ; 00-398650AG, Lot Number 20JBJ100 ; 00-398650AG, Lot Number 21ABP363 ; 00-398650AG, Lot Number 21ABQ027 ; 00-398650AI, Lot Number 21FBT441 ; 00-398650AI, Lot Number 21IBH355 ; 00-398650AI, Lot Number 21KBM869 ; 00-398650AI, Lot Number 21LBH937 ; 00-398650AI, Lot Number 22BBA596 ; 00-398650AI, Lot Number 22CBY494 ; 00-398650AI, Lot Number 22DBQ496 ; 00-398650AI, Lot Number 22FBL546 ; 00-398650AI, Lot Number 22GBJ321 ; 00-398650AI, Lot Number 22JBE607 ; 00-398650AI, Lot Number 22JBE609 ; 00-398650AI, Lot Number 21EBB527 ; 00-398712S , Lot Number 19KMA101 ; 00-398712S , Lot Number 19LMB722 ; 00-398712S , Lot Number 20CMA260 ; 00-398712S , Lot Number 20CMC911 ; 00-398712S , Lot Number 20FMA921 ; 00-398712S , Lot Number 20GMB435 ; 00-398712S , Lot Number 20IMA653 ; 00-398712S , Lot Number 20KMA809 ; 00-398712S , Lot Number 20LMD895 ; 00-398712S , Lot Number 21CMD722 ; 00-398712S , Lot Number 21EMF323 ; 00-398712S , Lot Number 21HMB142 ; 00-398712S , Lot Number 21IMB825 ; 00-398712S , Lot Number 21JMH910 ; 00-398712S , Lot Number 21LMG148 ; 00-398712S , Lot Number 22BMH320 ; 00-398712S , Lot Number 22DME594 ; 00-398712S , Lot Number 22HMI166 ; 00-398712S , Lot Number 22JME059 ; 00-398712S , Lot Number 23AME236 ; 00-398712S , Lot Number 23DME416 ; 00-398712S , Lot Number 23FMG905 ; 00-398712S , Lot Number 23IMF984 ; 00-398712S , Lot Number 23KMF990 ; 00-398712S , Lot Number 19BKB212 ; 00-398712S , Lot Number 19CKB198 ; 00-398712S , Lot Number 19EKB257 ; 00-398712S , Lot Number 19GKC485 ; 00-398712S , Lot Number 19IKA568 ; 00-398712S , Lot Number 19IKB991 ; 00-398725AM, Lot Number 21FBJ550 ; 00-398725AM, Lot Number 19IBJ529 ; 00-398725AM, Lot Number 19KBS571 ; 00-398725AM, Lot Number 19KBU397 ; 00-398725AM, Lot Number 20BBE698 ; 00-398725AM, Lot Number 20CBG353 ; 00-398725AM, Lot Number 20DBI198 ; 00-398725AM, Lot Number 20FBB296 ; 00-398725AM, Lot Number 20FBC302 ; 00-398725AM, Lot Number 20GBF723 ; 00-398725AM, Lot Number 20HBM698 ; 00-398725AM, Lot Number 20LBR908 ; 00-398725AM, Lot Number 21BBE202 ; 00-398725AM, Lot Number 21DBD638 ; 00-399360K , Lot Number 21VBC685 ; 00-399360K , Lot Number 23FBU384 ; 00-399360K , Lot Number 23IBA381 ; 00-399360K , Lot Number 23KBE043 ; 00-399360K , Lot Number 23LBR853 ; 00-399734N , Lot Number 23JBU818 ; 00-399734N , Lot Number 23KBI990 ; 00-399734N , Lot Number 23LBV170 ; 00-399734N , Lot Number 19ADB519 ; 00-399734N , Lot Number 19BDB357 ; 00-399734N , Lot Number 19DDA161 ; 00-399734N , Lot Number 19EDA281 ; 00-399734N , Lot Number 19EDC270 ; 00-399734N , Lot Number 19GDA275 ; 00-399734N , Lot Number 19IDA132 ; 00-399734N , Lot Number 19LMA267 ; 00-399734N , Lot Number 20BMA475 ; 00-399734N , Lot Number 20DMA774 ; 00-399734N , Lot Number 20GMB326 ; 00-399734N , Lot Number 20IMD767 ; 00-399734N , Lot Number 20JMC215 ; 00-399734N , Lot Number 21DMA867 ; 00-399734N , Lot Number 21DME739 ; 00-399734N , Lot Number 21FMF556 ; 00-399734N , Lot Number 21IMA047 ; 00-399734N , Lot Number 21JME290 ; 00-399734N , Lot Number 21JMH037 ; 00-399734N , Lot Number 22CMF020 ; 00-399734N , Lot Number 22DMF495 ; 00-399734N , Lot Number 22GMB900 ; 00-399734N , Lot Number 22IMA125 ; 00-399734N , Lot Number 22JME374 ; 00-399734N , Lot Number 22LMB989 ; 00-399734N , Lot Number 23DMA849 ; 00-399734N , Lot Number 23EMC285 ; 00-399734N , Lot Number 23EMJ483 ; 00-399983Q , Lot Number 19BBE921 ; 00-3
Risk classification: Class II
Area (FDA): device
Country: United States

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