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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1097-2024

MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976

Publicado el 6 de marzo de 2024 · Inicio del retiro: 15 de noviembre de 2023

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
MEDLINE INDUSTRIES, LP - Northfield
Distribuidor
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Lote
a) REF DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers: 23CMB532, 23CME753, 23EMD721, 23FMH948; b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers: c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132; d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers: 22ABH235, 22BBF113, 22IBG479; e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers: 22ABZ109, 22BBK108; f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers: 22ABP582, 22CBP735, 22JBK237, 22LBK168; g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653; h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers: 21LBK271, 22ABS686; i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers: 22CBS571, 22DBO302, 22IBG350; j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197; k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers: 22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230; n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers: 22DMC487, 23AMB416, 23BMF491, 23FMD563; o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers: 22ABJ804, 22BBA095, 22IBG184, 22OBE089; p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers: 22ABJ710, 22CBV307, 22CBX726, 22OBA248; q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers: 22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995; r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers: 22BBW666, 22HBT170; u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers: 22ABY200, 22HBH109; v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268; y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers: 23BMF842; z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers: 22EBE126, 22HBC049, 22IBG224; aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers: 22BBG415, 22DBE305, 22MBA761; bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers: 22CBE020, 22EBP942; cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers: 22FLA161; dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers: 22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576; ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587; ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587 gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers: 22IBG588; hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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