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FDAFDA · Food and drugs·Recall number Z-2634-2024

Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number DYNDH1697; 11) PAIN MANAGEMENT PACK, Pack Number DYNDH1697A ; 12) EPIDURAL TRAY , Pack Number DYNDH1739; 13) PAIN MANAGEMENT TRAY, Pack Number DYNDH1823; 14) PAIN KIT MARSHFIELD , Pack Number DYNDH1842; 15) PAIN TRAY , Pack Number DYNDH1938; 16) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290C ; 17) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290D ; 18) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290F ; 19) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378G ; 20) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378I ; 21) STERILE PAIN PACK-LF, Pack Number DYNJ0384670F ; 22) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265G ; 23) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265I ; 24) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265J ; 25) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265K ; 26) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265L ; 27) EPIDURAL PAIN INJ (O.I) PK-LF, Pack Number DYNJ0429265M; 28) PANCREAS DONOR PACK-LF, Pack Number DYNJ0429318F ; 29) MINOR ACUTE PACK-LF , Pack Number DYNJ0484979C ; 30) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0487701G ; 31) LOCAL PACK-LF , Pack Number DYNJ0554526I ; 32) ESI PACK-LF , Pack Number DYNJ0562716G ; 33) PAIN MANAGEMENT - EDOC PACK-LF, Pack Number DYNJ0625993I; 34) BGMC MJR ORAL/MAXILLO PACK-LF , Pack Number DYNJ0664646B ; 35) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964J ; 36) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964K ; 37) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964L ; 38) DSA PACK-LF , Pack Number DYNJ0843713D ; 39) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0904575C ; 40) LOCALS PACK-LF, Pack Number DYNJ0939707; 41) EP TRAY , Pack Number DYNJ21808D ; 42) PAIN MANAGEMENT , Pack Number DYNJ26879B ; 43) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384L ; 44) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384M ; 45) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384N ; 46) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384O ; 47) FACET , Pack Number DYNJ28549D ; 48) PAIN MANAGEMENT PACK, Pack Number DYNJ30042A ; 49) PAIN MANAGEMENT KIT , Pack Number DYNJ30500; 50) PAIN MANAGEMENT KIT , Pack Number DYNJ30500A ; 51) PAIN BLOCKS PACK, Pack Number DYNJ31717B ; 52) PAIN BLOCKS PACK, Pack Number DYNJ31717C ; 53) PAIN BLOCKS PACK, Pack Number DYNJ31717D ; 54) RADIOLOGY EPIDURAL 0906005-LF , Pack Number DYNJ32775K ; 55) UNIVERSAL BLOCK TRAY;EXT LINE , Pack Number DYNJ33057; 56) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352B ; 57) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352C ; 58) LOCAL BASIC , Pack Number DYNJ34418I ; 59) LOCAL BASIC , Pack Number DYNJ34418L ; 60) LOCAL BASIC , Pack Number DYNJ34418M ; 61) PATIENT PREP TRAY , Pack Number DYNJ34489D ; 62) SOFT PAIN TRAY-LF , Pack Number DYNJ35270C ; 63) PAIN MANAGEMENT , Pack Number DYNJ36528A ; 64) PAIN MANAGEMENT , Pack Number DYNJ36528B ; 65) LOCAL PROCEDURE PACK, Pack Number DYNJ38148C ; 66) LOCAL PROCEDURE PACK, Pack Number DYNJ38148D ; 67) BASIC PAIN PACK-LF, Pack Number DYNJ38623F ; 68) BASIC PAIN PACK-LF, Pack Number DYNJ38623G ; 69) BASIC PAIN PACK-LF, Pack Number DYNJ38623I; 70) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number DYNJ39178B ; 71) PAIN PROCEDURE PACK , Pack Number DYNJ40804D ; 72) BLOCK PACK, Pack Number DYNJ44205B ; 73) BLOCK PACK, Pack Number DYNJ44205D ; 74) EP PACK 319704, Pack Number DYNJ44602C ; 75) PAIN PACK , Pack Number DYNJ45913A ; 76) PAIN PACK , Pack Number DYNJ45913B ; 77) PAIN PACK , P

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
CDS985445B , Lot Number 19ABK040 ; CDS985445B , Lot Number 19ABV498 ; CDS985445B , Lot Number 19BBN825 ; CDS985445B , Lot Number 19EBG359 ; CDS985445B , Lot Number 19FBA393 ; CDS985445B , Lot Number 19GBC446 ; CDS985445B , Lot Number 19HBM036 ; CDS985445B , Lot Number 19JBS476 ; CDS985445B , Lot Number 19LBC804 ; CDS985445B , Lot Number 20BBA618 ; CDS985445B , Lot Number 20CBI761 ; CDS985445B , Lot Number 20DBM201 ; CDS985445B , Lot Number 21ABX275 ; CDS985445B , Lot Number 21CBG480 ; CDS985445B , Lot Number 21CBV955 ; CDS985445B , Lot Number 21DBQ516 ; CDS985445C , Lot Number 21IBP827 ; CDS985445C , Lot Number 21KBO008 ; CDS985445C , Lot Number 22BBK102 ; CDS985445C , Lot Number 22OBI304 ; CDS985445C , Lot Number 22EBI120 ; CDS985445C , Lot Number 22GBP605 ; CDS985445C , Lot Number 22GBU597 ; CDS985445C , Lot Number 22GBY036 ; CDS985445C , Lot Number 22HMG268 ; CDS985445C , Lot Number 22HMH893 ; CDS985445C , Lot Number 22JME066 ; CDS985445C , Lot Number 22KMC551 ; CDS985445C , Lot Number 22LMA461 ; CDS985445C , Lot Number 22LMC730 ; CDS985445C , Lot Number 23AMG434 ; CDS985445C , Lot Number 23FMC235 ; CDS985445C , Lot Number 23GME307 ; CDS985445C , Lot Number 23JMF730 ; DYNDA1233B , Lot Number 21JBQ010 ; DYNDA2402A , Lot Number 22JBE471 ; DYNDA2402A , Lot Number 22JBH025 ; DYNDA2402A , Lot Number 22KBU699 ; DYNDA2402A , Lot Number 23ABN842 ; DYNDA2402A , Lot Number 23CBM334 ; DYNDA2402A , Lot Number 23EBS527 ; DYNDA2402A , Lot Number 23HBL655 ; DYNDA2402A , Lot Number 23HBZ380 ; DYNDA2402A , Lot Number 23IBO904 ; DYNDA2402A , Lot Number 23KBE880 ; DYNDA2795, Lot Number 24DMD278; DYNDA2795, Lot Number 21HBS958 ; DYNDA2965, Lot Number 23JBE036; DYNDH1094, Lot Number 22NBD305 ; DYNDH1094, Lot Number 22DBE033 ; DYNDH1094, Lot Number 20ABB780 ; DYNDH1094, Lot Number 21DBO182 ; DYNDH1239D, Lot Number 23LBM683; DYNDH1239D, Lot Number 23IBP933; DYNDH1239D, Lot Number 23GBM258; DYNDH1239D, Lot Number 23FBI290; DYNDH1239D, Lot Number 23EBQ559; DYNDH1239D, Lot Number 23EBA717; DYNDH1239D, Lot Number 23CBN999; DYNDH1239D, Lot Number 23BBF912; DYNDH1351B , Lot Number 23IBK337 ; DYNDH1351B , Lot Number 23IBP041 ; DYNDH1351B , Lot Number 24ABU967 ; DYNDH1697, Lot Number 22OBC291 ; DYNDH1697A , Lot Number 22EBO835 ; DYNDH1697A , Lot Number 22GBG348 ; DYNDH1697A , Lot Number 22GBT117 ; DYNDH1697A , Lot Number 22HBK868 ; DYNDH1697A , Lot Number 22LBK070 ; DYNDH1697A , Lot Number 23EBN655 ; DYNDH1697A , Lot Number 23HBA924 ; DYNDH1697A , Lot Number 23IBI146 ; DYNDH1739, Lot Number 22GBL404 ; DYNDH1823, Lot Number 23BBB753 ; DYNDH1823, Lot Number 23BBE219 ; DYNDH1823, Lot Number 23IBD247 ; DYNDH1823, Lot Number 23KBV196 ; DYNDH1842, Lot Number 23CBT676 ; DYNDH1842, Lot Number 23FBT257 ; DYNDH1842, Lot Number 23IBH272 ; DYNDH1842, Lot Number 23LBD600 ; DYNDH1842, Lot Number 24ABU174 ; DYNDH1938, Lot Number 24ABW727 ; DYNJ0101290C , Lot Number 19JDB788 ; DYNJ0101290C , Lot Number 19JDC881 ; DYNJ0101290C , Lot Number 20CDA654 ; DYNJ0101290C , Lot Number 20DDA178 ; DYNJ0101290C , Lot Number 19BKA426 ; DYNJ0101290C , Lot Number 19BKD023 ; DYNJ0101290D , Lot Number 20DDB895 ; DYNJ0101290D , Lot Number 20JDA393 ; DYNJ0101290D , Lot Number 20JDC188 ; DYNJ0101290D , Lot Number 21JDA438 ; DYNJ0101290D , Lot Number 22HDC372 ; DYNJ0101290F , Lot Number 22LDA180 ; DYNJ0377378G , Lot Number 19BKC333 ; DYNJ0377378G , Lot Number 19EKC184 ; DYNJ0377378I , Lot Number 20JMC343 ; DYNJ0377378I , Lot Number 21JME663 ; DYNJ0377378I , Lot Number 22AMB470 ; DYNJ0377378I , Lot Number 19GKC949 ; DYNJ0377378I , Lot Number 19IKA160 ; DYNJ0377378I , Lot Number 20CKA396 ; DYNJ0384670F , Lot Number 19CBE146 ; DYNJ0384670F , Lot Number 22GBZ306 ; DYNJ0429265G , Lot Number 19GMA086 ; DYNJ0429265G , Lot Number 19HMB053 ; DYNJ0429265G , Lot Number 19JMB654 ; DYNJ0429265G , Lot Number 19LMB364 ; DYNJ0429265G , Lot Number 20CMC042 ; DYNJ0429265G , Lot Number 20FMC350 ; DYNJ
Risk classification
Class II
Area (FDA)
device
Country
United States

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