medical Class II Updated 2025-04-02

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) A & A KNEE PACK-LF,

Recalled Product

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385; 21) CT BASIC PACK, Pack Number DYNJ51617A; 22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I; 23) CYSTO, Pack Number DYNJ24351D; 24) CYSTO PACK, Pack Number DYNJ62359A; 25) DAVINCI PACK, Pack Number DYNJ04113C; 26) DUPYTRENS PACK, Pack Number DYNJ60496; 27) EH PACEMAKER PACK, Pack Number DYNJ55734C; 28) EVLT PACK, Pack Number DYNJ45997C; 29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G; 30) GENERAL BASIC PACK, Pack Number DYNJ82039; 31) GENERAL PURPOSE CV, Pack Number DYNJ904395F; 32) GENERAL UTILITY PACK, Pack Number DYNJ45093B; 33) HP DEVICE-LF, Pack Number DYNJ62255A; 34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B; 35) IR PACK, Pack Number DYNJ32080L; 36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857; 37) IR TABLE PACK II, Pack Number DYNJ56298B; 38) JVL-PACK TUNNELED, Pack Number DYNJ66065; 39) LITHOTOMY PACK, Pack Number DYNJ66490B; 40) LITHOTOMY PACK, Pack Number DYNJ65380A; 41) LOOP RECORDER PACK, Pack Number DYNJ53221B; 42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A; 43) MAJOR BASIN PACK, Pack Number DYNJ67484A; 44) MAJOR PACK, Pack Number DYNJ51996; 45) MAJOR PACK-LF, Pack Number DYNJ24599I; 46) MINI PACK, Pack Number DYNJ52305D; 47) MINI SET UP KIT, Pack Number DYNJ81562; 48) MINOR BASIN, Pack Number DYNJ43021B; 49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286; 50) MINOR PACK-LF, Pack Number DYNJ0551383P; 51) MINOR PK-LF, Pack Number DYNJ21408D; 52) MINOR WAKEFIELD, Pack Number DYNJ58872A; 53) MYELOGRAM TRAY, Pack Number DYNDH1775A; 54) OB PACK, Pack Number DYNJ32216B; 55) OPEN STERILE PACK, Pack Number DYNJ62104A; 56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B; 57) PACK URO-BASIC, Pack Number DYNJ38246A; 58) PACK,LTD BODY SSP, Pack Number DYNJ65488B; 59) PARACENTESIS, Pack Number DYNJ44505B; 60) PBMS NECK PACK-LF, Pack Number DYNJ64961A; 61) PEDI MAJOR PACK, Pack Number DYNJ40062K; 62) PEDI PK-LF, Pack Number DYNJ21240J; 63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B; 64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B; 65) PK, GEN-MINOR, Pack Number DYNJ59461C; 66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B; 67) PK, URO-CYSTO-MH, Pack Number DYNJ62501; 68) PK-GEN-BASIC, Pack Number DYNJ42382B; 69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B; 70) PODIATRY PACK, Pack Number DYNJ37297D; 71) PST PACK, Pack Number DYNJ62666; 72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J; 73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A; 74) SHUNT PACK-LF, Pack Number PHS967363W; 75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242; 76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X; 77) STANDARD ICL PACK-LF, Pack Number PHS895675B; 78) T & A PK-LF, Pack Number DYNJT2408C; 79) THORACIC PACK SHD, Pack Number DYNJ68416C; 80) TONSIL PACK-LF, Pack Number DYNJ0553334I; 81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I; 82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M; 83) VASECTOMY PACK, Pack Number DYNJ65326; 84) VASECTOMY PACK,


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) Pack Number DYNJHS0136D: UDI/DI 10889942848973 (each) 40889942848974 (case), Lot Number 22JBC557Z; 2) Pack Number DYNJ56987B: UDI/DI 10889942868193 (each) 40889942868194 (case), Lot Number 21EBN072A; 3) Pack Number PHS170994005A: UDI/DI 10888277754379 (each) 40888277754370 (case), Lot Number 21IMG402A; 4) Pack Number DYNJ54836B: UDI/DI 10193489574128 (each) 40193489574129 (case), Lot Number 21BBH689A; 5) Pack Number DYNJ58678A: UDI/DI 10888277781207 (each) 40888277781208 (case), Lot Number 21GMF677A; 6) Pack Number DYNJ63532: UDI/DI 10193489748468 (each) 40193489748469 (case), Lot Number 22CMB574A; 7) Pack Number DYNJ81702: UDI/DI 10195327135447 (each) 40195327135448 (case), Lot Number 23CBF695A; 8) Pack Number DYNJ36595D: UDI/DI 10193489928976 (each) 40193489928977 (case), Lot Number 23CBL653A; 9) Pack Number DYNJ69250A: UDI/DI 10195327142315 (each) 40195327142316 (case), Lot Number 23HME051A; 10) Pack Number DYNJ50470C: UDI/DI 10889942922611 (each) 40889942922612 (case), Lot Number 23FME520A; 11) Pack Number DYNJ0115839A: UDI/DI 10193489901764 (each) 40193489901765 (case), Lot Number 23FME450A; 12) Pack Number PHS396134006A: UDI/DI 10889942694303 (each) 40889942694304 (case), Lot Number 23DDA331A; 13) Pack Number DYNJ20114Q: UDI/DI 10193489549249 (each) 40193489549240 (case), Lot Number 22JBF822Z; 14) Pack Number DYNJ0375705L: UDI/DI 10193489544138 (each) 40193489544139 (case), Lot Number 22GBP901M; 15) Pack Number DYNJ38051F: UDI/DI 10193489909319 (each) 40193489909310 (case), Lot Number 23EMC825A; 16) Pack Number DYNJ0161358B: UDI/DI 10889942213269 (each) 40889942213260 (case), Lot Number 23DDA354A; 17) Pack Number DYNJ50844B: UDI/DI 10889942883271 (each) 40889942883272 (case), Lot Number 22GMD340Z; 18) Pack Number DYNJ46776C: UDI/DI 10889942893218 (each) 40889942893219 (case), Lot Number 21BBE822A; 19) Pack Number DYNJ40640B: UDI/DI 10193489292145 (each) 40193489292146 (case), Lot Number 21IME326A; 20) Pack Number DYNJ39385: UDI/DI 10884389765067 (each) 40884389765068 (case), Lot Number 21IMD121A; 21) Pack Number DYNJ51617A: UDI/DI 10889942448616 (each) 40889942448617 (case), Lot Number 20LKB440A; 22) Pack Number DYNJ06672I: UDI/DI 10889942725830 (each) 40889942725831 (case), Lot Number 23BBU700A; 23) Pack Number DYNJ24351D: UDI/DI 10193489738841 (each) 40193489738842 (case), Lot Number 21LBD180A; 24) Pack Number DYNJ62359A: UDI/DI 10193489202571 (each) 40193489202572 (case), Lot Number 20AKB925A; 25) Pack Number DYNJ04113C: UDI/DI 10889942934102 (each) 40889942934103 (case), Lot Number 21EBP303A; 26) Pack Number DYNJ60496: UDI/DI 10193489506174 (each) 40193489506175 (case), Lot Number 22GBU071Z; 27) Pack Number DYNJ55734C: UDI/DI 10889942779093 (each) 40889942779094 (case), Lot Number 20FMA632A; 28) Pack Number DYNJ45997C: UDI/DI 10889942684366 (each) 40889942684367 (case), Lot Number 23GBF502A; 29) Pack Number DYNJ51799G: UDI/DI 10193489475944 (each) 40193489475945 (case), Lot Number 22CDB465A; 30) Pack Number DYNJ82039: UDI/DI 10195327163877 (each) 40195327163878 (case), Lot Number 23EBE702A; 31) Pack Number DYNJ904395F: UDI/DI 10193489701333 (each) 40193489701334 (case), Lot Number 22FBS141Z; 32) Pack Number DYNJ45093B: UDI/DI 10195327044213 (each) 40195327044214 (case), Lot Number 23BLB075A; 33) Pack Number DYNJ62255A: UDI/DI 10193489276671 (each) 40193489276672 (case), Lot Number 22GBU775A; 34) Pack Number DYNJ42231B: UDI/DI 10193489948165 (each) 40193489948166 (case), Lot Number 21HMB550A; 35) Pack Number DYNJ32080L: UDI/DI 10193489691900 (each) 40193489691901 (case), Lot Number 21BBJ386A; 36) Pack Number DYNJ64857: UDI/DI 10193489223361 (each) 40193489223362 (case), Lot Number 21IME211A; 37) Pack Number DYNJ56298B: UDI/DI 10193489415902 (each) 40193489415903 (case), Lot Number 21HME360A; 38) Pack Number DYNJ66065: UDI/DI 10193489319187 (each) 40193489319188 (case), Lot Number 23LMG850A; 39) Pack Number DYNJ66490B: UDI/DI 10195327472962 (each) 40195327472963 (case), Lot Number 23HMC391A; 40) Pack Number DYNJ65380A: UDI/DI 10195327418083 (each) 40195327418084 (case), Lot Number 23LMF918A; 41) Pack Number DYNJ53221B: UDI/DI 10193489922288 (each) 40193489922289 (case), Lot Number 23GMC211A; 42) Pack Number DYNJ48058A: UDI/DI 10193489325669 (each) 40193489325660 (case), Lot Number 21JMH979A; 43) Pack Number DYNJ67484A: UDI/DI 10195327020743 (each) 40195327020744 (case), Lot Number 23DME735A; 44) Pack Number DYNJ51996: UDI/DI 10889942233205 (each) 40889942233206 (case), Lot Number 21BBG178A; 45) Pack Number DYNJ24599I: UDI/DI 10193489315141 (each) 40193489315142 (case), Lot Number 21IMH674A; 46) Pack Number DYNJ52305D: UDI/DI 10195327028572 (each) 40195327028573 (case), Lot Number 22JBU974A; 47) Pack Number DYNJ81562: UDI/DI 10195327122539 (each) 40195327122530 (case), Lot Number 22JBW597A; 48) Pack Number DYNJ43021B: UDI/DI 10193489258851 (each) 40193489258852 (case), Lot Number 21GMC689A; 49) Pack Number DYNJ69286: UDI/DI 10193489922189 (each) 40193489922180 (case), Lot Number 23IMF699A; 50) Pack Number DYNJ0551383P: UDI/DI 10889942962143 (each) 40889942962144 (case), Lot Number 21GMB523A; 51) Pack Number DYNJ21408D: UDI/DI 10195327053642 (each) 40195327053643 (case), Lot Number 21LMF738A; 52) Pack Number DYNJ58872A: UDI/DI 10193489751871 (each) 40193489751872 (case), Lot Number 23JBW564A; 53) Pack Number DYNDH1775A: UDI/DI 10195327362218 (each) 40195327362219 (case), Lot Number 23LBM803Z; 54) Pack Number DYNJ32216B: UDI/DI 10193489546101 (each) 40193489546102 (case), Lot Number 21BBF074A; 55) Pack Number DYNJ62104A: UDI/DI 10193489763713 (each) 40193489763714 (case), Lot Number 23FBO390A; 56) Pack Number DYNJ60124B: UDI/DI 10193489982855 (each) 40193489982856 (case), Lot Number 21LMG031A; 57) Pack Number DYNJ38246A: UDI/DI 10884389757772 (each) 40884389757773 (case), Lot Number 23BBQ828A; 58) Pack Number DYNJ65488B: UDI/DI 10193489443646 (each) 40193489443647 (case), Lot Number 23LMG039A; 59) Pack Number DYNJ44505B: UDI/DI 10889942379248 (each) 40889942379249 (case), Lot Number 20BDB430A; 60) Pack Number DYNJ64961A: UDI/DI 10193489416039 (each) 40193489416030 (case), Lot Number 23IMF244A; 61) Pack Number DYNJ40062K: UDI/DI 10195327493325 (each) 40195327493326 (case), Lot Number 23LMF453A; 62) Pack Number DYNJ21240J: UDI/DI 10889942931378 (each) 40889942931379 (case), Lot Number 21IMH809A; 63) Pack Number DYNJ51725B: UDI/DI 10193489538731 (each) 40193489538732 (case), Lot Number 21KBJ357A; 64) Pack Number DYNJ55355B: UDI/DI 10195327173784 (each) 40195327173785 (case), Lot Number 23CBN280A; 65) Pack Number DYNJ59461C: UDI/DI 10195327510107 (each) 40195327510108 (case), Lot Number 24ABA333Z; 66) Pack Number DYNJ43754B: UDI/DI 10193489808964 (each) 40193489808965 (case), Lot Number 20HMD448A; 67) Pack Number DYNJ62501: UDI/DI 10193489664829 (each) 40193489664820 (case), Lot Number 21LBB961A; 68) Pack Number DYNJ42382B: UDI/DI 10195327253288 (each) 40195327253289 (case), Lot Number 23LMG144A; 69) Pack Number DYNJ41824B: UDI/DI 10889942933488 (each) 40889942933489 (case), Lot Number 21LBW098A; 70) Pack Number DYNJ37297D: UDI/DI 10193489566567 (each) 40193489566568 (case), Lot Number 21JMH963A; 71) Pack Number DYNJ62666: UDI/DI 10193489679663 (each) 40193489679664 (case), Lot Number 23BBR333A; 72) Pack Number DYNJ0785683J: UDI/DI 10193489709315 (each) 40193489709316 (case), Lot Number 23LMD781A; 73) Pack Number DYNJ43502A: UDI/DI 10193489767858 (each) 40193489767859 (case), Lot Number 21BBI542A; 74) Pack Number PHS967363W: UDI/DI 10889942924561 (each) 40889942924562 (case), Lot Number 21LME249A; 75) Pack Number DYNJ30242: UDI/DI 10080196785834 (each) 40080196785835 (case), Lot Number 23LMG145A; 76) Pack Number DYNJ0129513X: UDI/DI 10195327511876 (each) 40195327511877 (case), Lot Number 23LMG678A; 77) Pack Number PHS895675B: UDI/DI 10193489418316 (each) 40193489418317 (case), Lot Number 22IMB409A; 78) Pack Number DYNJT2408C: UDI/DI 10884389367643 (each) 40884389367644 (case), Lot Number 21AMA394A; 79) Pack Number DYNJ68416C: UDI/DI 10195327341688 (each) 40195327341689 (case), Lot Number 23LBS810Z; 80) Pack Number DYNJ0553334I: UDI/DI 10193489513646 (each) 40193489513647 (case), Lot Number 23HME093A; 81) Pack Number DYNJ0375928I: UDI/DI 10193489544220 (each) 40193489544221 (case), Lot Number 23CBB970A; 82) Pack Number DYNJ0416615M: UDI/DI 10195327518936 (each) 40195327518937 (case), Lot Number 24DMC685Z; 83) Pack Number DYNJ65326: UDI/DI 10193489267587 (each) 40193489267588 (case), Lot Number 21LBG918A; 84) Pack Number DYNJ84729: UDI/DI 10195327407247 (each) 40195327407248 (case), Lot Number 23GBV524A; 85) Pack Number DYNJ57459A: UDI/DI 10888277759596 (each) 40888277759597 (case), Lot Number 22GBE165A; 86) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case), Lot Number 22GDB223A; 87) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case), Lot Number 23EDA439A
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