FDAFDA · Food and drugs·Recall number Z-2635-2024
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NERVE BLOCK ACCESSORY PACK, Pack Number DYNJ0134147D ; 7) UNIVERSAL PROC TRAY-LF, Pack Number DYNJ02120B ; 8) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AJ; 9) CUSTOM BLOCK KEMP PACK-LF , Pack Number DYNJ0371999G ; 10) PAIN MANAGEMENT PACK-LF , Pack Number DYNJ0374104F ; 11) THORASCOPIC - UNIV, Pack Number DYNJ0375880O ; 12) ANGIOGRAPHIC PACK II-LF , Pack Number DYNJ0543507AB; 13) GM ANGIOGRAPHY PACK-LF, Pack Number DYNJ0621584Y ; 14) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0689247S ; 15) PERI NEURO BLOCK PACK-LF, Pack Number DYNJ0703127A ; 16) MAJOR HEAD/NECK PACK-LF , Pack Number DYNJ0826705L ; 17) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047C ; 18) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047CH; 19) NECK PACK , Pack Number DYNJ17213C ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ20085K ; 21) ANGIO CATH PACK-MARY IMMACULAT, Pack Number DYNJ24517D ; 22) PAIN MANAGEMENT , Pack Number DYNJ26879A ; 23) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJ32412B ; 24) UNIVERSAL BLOCK TRAY, Pack Number DYNJ32680; 25) ANGIOGRAM TRAY, Pack Number DYNJ33638J ; 26) NERVE BLOCK PACK-LF , Pack Number DYNJ34351B ; 27) PATIENT PREP TRAY , Pack Number DYNJ34489C ; 28) UNIVERSAL MAJOR PACK-LF , Pack Number DYNJ35760B ; 29) BLOCK-LF, Pack Number DYNJ36152A ; 30) TRANSFORAMINAL PACK , Pack Number DYNJ36406B ; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJ36781; 32) RADIOFREQUENCY PACK , Pack Number DYNJ37338C ; 33) MAJOR NEURO VCH , Pack Number DYNJ39218D ; 34) NEPHROSTOMY PACK, Pack Number DYNJ41069A ; 35) CVOR ANGIOGRAPHY PACK-LF, Pack Number DYNJ42367B ; 36) BLOCK PACK, Pack Number DYNJ44205C ; 37) NECK PACK-LF, Pack Number DYNJ46059A ; 38) UNIVERSAL RVHS-LF , Pack Number DYNJ46874; 39) BLOCK KIT-LF, Pack Number DYNJ47338; 40) ANGIO KIT , Pack Number DYNJ48177A ; 41) UNIVERSAL CORE DR RUNNELS PACK, Pack Number DYNJ52230; 42) ANGIO PACK-LF , Pack Number DYNJ52898B ; 43) NEPHROLOGY PACK , Pack Number DYNJ59089; 44) MAJOR ANGIO , Pack Number DYNJ59301A ; 45) NIJHER PAIN PACK, Pack Number DYNJ62009C; 46) NIJHER PAIN PACK, Pack Number DYNJ62009C ; 47) O NEILL PAIN PACK , Pack Number DYNJ62011C ; 48) NEPHROLOGY PACK , Pack Number DYNJ62930; 49) NEPHROLOGY PACK , Pack Number DYNJ63200A ; 50) NEURO GOODIE PACK - DUNN, Pack Number DYNJ64570; 51) THROMBECTOMY PACK - NEUROS, Pack Number DYNJ64580; 52) RADIOFREQUENCY, Pack Number DYNJ68289; 53) EPIDURAL PACK, Pack Number DYNJ68840A; 54) EPIDURAL PACK , Pack Number DYNJ68840A ; 55) NEURO , Pack Number DYNJ901405K; 56) NEURO LUMBAR, Pack Number DYNJ904111G; 57) NERVE BLOCK TRAY-LF , Pack Number DYNJRA0022A; 58) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0031B; 59) UNIVERSAL BLOCK PAIN PK , Pack Number DYNJRA0041 ; 60) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044 ; 61) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044A; 62) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044B; 63) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0050A; 64) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0051B; 65) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0052 ; 66) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0087B; 67) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0104B; 68) UNIVERSAL BLOCK SPINAL-LF , Pack Number DYNJRA0105B; 69) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0110A; 70) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0111; 71) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0139D; 72) PAIN CLINIC , Pack Number DYNJRA0173B; 73) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0179 ; 74) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0186C; 75) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0187B; 76) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0191C; 77) NERVE BLOCK TRAY (FACET)-LF , Pack Number DYNJRA0207A; 78) NERVE
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
- CDS981579O , Lot Number 21JBM647 ; CDS981579O , Lot Number 21JBQ860 ; CDS981579O , Lot Number 22CBX741 ; CDS981579O , Lot Number 19EBL586 ; CDS981579O , Lot Number 19GBJ538 ; CDS981579O , Lot Number 19IBH976 ; CDS981579O , Lot Number 19JBZ536 ; CDS981579O , Lot Number 19KBB918 ; CDS981579O , Lot Number 20ABP061 ; CDS981579O , Lot Number 20BBA647 ; CDS981579O , Lot Number 20DBM006 ; CDS981579O , Lot Number 20FBS525 ; CDS981579O , Lot Number 21ABO831 ; CDS981579O , Lot Number 21BBI363 ; CDS981579O , Lot Number 21CBI409 ; CDS981579O , Lot Number 21DBG604 ; CDS981579O , Lot Number 21FBC673 ; DYNDA2391, Lot Number 21JBR496 ; DYNDA2508, Lot Number 19FBY839 ; DYNDL1389, Lot Number 22FMG166; DYNDL1389, Lot Number 22DMC258; DYNDL1389, Lot Number 22NBA716; DYNJ0117039, Lot Number 19ALA192 ; DYNJ0117039, Lot Number 19FLA299 ; DYNJ0117039, Lot Number 19LLA121 ; DYNJ0117039, Lot Number 20ALA869 ; DYNJ0117039, Lot Number 20CLA195 ; DYNJ0117039, Lot Number 20GLA412 ; DYNJ0117039, Lot Number 20ILA113 ; DYNJ0117039, Lot Number 20JLA806 ; DYNJ0117039, Lot Number 20KLA286 ; DYNJ0117039, Lot Number 21ALA145 ; DYNJ0134147D , Lot Number 21JBP263 ; DYNJ0134147D , Lot Number 22ABI678 ; DYNJ0134147D , Lot Number 22EMB713 ; DYNJ0134147D , Lot Number 23CMA573 ; DYNJ0134147D , Lot Number 23GMB375 ; DYNJ0134147D , Lot Number 19AKA640 ; DYNJ0134147D , Lot Number 19BKA636 ; DYNJ0134147D , Lot Number 19CKD047 ; DYNJ0134147D , Lot Number 19EKC644 ; DYNJ0134147D , Lot Number 19GKC561 ; DYNJ0134147D , Lot Number 19IKB159 ; DYNJ0134147D , Lot Number 19JKC253 ; DYNJ0134147D , Lot Number 20AKA947 ; DYNJ0134147D , Lot Number 20BKB449 ; DYNJ0134147D , Lot Number 20EKA818 ; DYNJ0134147D , Lot Number 20GKA349 ; DYNJ0134147D , Lot Number 21AKA686 ; DYNJ02120B , Lot Number 19ELA164 ; DYNJ0298504AJ, Lot Number 20LLA110 ; DYNJ0298504AJ, Lot Number 20LLA676 ; DYNJ0298504AJ, Lot Number 21ALA366 ; DYNJ0298504AJ, Lot Number 21BLA389 ; DYNJ0298504AJ, Lot Number 21DLA191 ; DYNJ0298504AJ, Lot Number 21ELA067 ; DYNJ0298504AJ, Lot Number 21ELA168 ; DYNJ0298504AJ, Lot Number 21GLB051 ; DYNJ0298504AJ, Lot Number 21HLA101 ; DYNJ0298504AJ, Lot Number 21ILA344 ; DYNJ0298504AJ, Lot Number 21ILA669 ; DYNJ0298504AJ, Lot Number 21JLB055 ; DYNJ0298504AJ, Lot Number 21LLA399 ; DYNJ0298504AJ, Lot Number 21LLA546 ; DYNJ0298504AJ, Lot Number 22ALA071 ; DYNJ0298504AJ, Lot Number 22BLA663 ; DYNJ0298504AJ, Lot Number 22CLA367 ; DYNJ0298504AJ, Lot Number 22DLA037 ; DYNJ0298504AJ, Lot Number 22DLA425 ; DYNJ0298504AJ, Lot Number 22ELA926 ; DYNJ0298504AJ, Lot Number 22GLA044 ; DYNJ0298504AJ, Lot Number 22ILA153 ; DYNJ0298504AJ, Lot Number 22JLA181 ; DYNJ0298504AJ, Lot Number 22JLA880 ; DYNJ0298504AJ, Lot Number 22KLA566 ; DYNJ0298504AJ, Lot Number 23ALA631 ; DYNJ0298504AJ, Lot Number 23BLA754 ; DYNJ0298504AJ, Lot Number 23CLB086 ; DYNJ0298504AJ, Lot Number 23DLB026 ; DYNJ0298504AJ, Lot Number 23ELA917 ; DYNJ0298504AJ, Lot Number 23FLB090 ; DYNJ0298504AJ, Lot Number 23HLA962 ; DYNJ0298504AJ, Lot Number 23ILA132 ; DYNJ0298504AJ, Lot Number 23ILB105 ; DYNJ0298504AJ, Lot Number 23JLB106 ; DYNJ0298504AJ, Lot Number 23LLA897 ; DYNJ0298504AJ, Lot Number 24ALA365 ; DYNJ0298504AJ, Lot Number 24ALA776 ; DYNJ0298504AJ, Lot Number 24CLA139 ; DYNJ0298504AJ, Lot Number 19LKA825 ; DYNJ0298504AJ, Lot Number 20AKC198 ; DYNJ0298504AJ, Lot Number 20DKB146 ; DYNJ0298504AJ, Lot Number 20EKB061 ; DYNJ0298504AJ, Lot Number 20GKA357 ; DYNJ0298504AJ, Lot Number 20JKB006 ; DYNJ0371999G , Lot Number 21LBW594 ; DYNJ0371999G , Lot Number 23BBP602 ; DYNJ0371999G , Lot Number 20HBR192 ; DYNJ0371999G , Lot Number 20HBX096 ; DYNJ0374104F , Lot Number 20KMC361 ; DYNJ0374104F , Lot Number 21AMA511 ; DYNJ0374104F , Lot Number 19BKB141 ; DYNJ0374104F , Lot Number 19CKA327 ; DYNJ0374104F , Lot Number 19EKA968 ; DYNJ0374104F , Lot Number 19EKC408 ; DYNJ0374104F , Lot Number 19HKD181 ; DYNJ0374104F , Lot Number 19JKB208 ; DYNJ0374104F
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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