FDAFDA · Alimentos y medicamentos·N.º oficial Z-1096-2024
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C
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 DYNDC3106, UDI/DI 40193489913270 (case), 10193489913279 (unit), Lot Numbers: 21LBT706, 22CBE273; b) REF DYKE1346D, UDI/DI 40195327114085 (case), 10195327114084 (unit), Lot Numbers: 22GBO510, 23BBG861, 23CBM313, 23EBN617, 23FBU655, 23GBR877, 23IBH963; c) REF DYKE1892A, UDI/DI 40195327430963 (case), 10195327430962 (unit), Lot Numbers: 10195327430962; d) REF DYKE1648G, UDI/DI 40195327007127 (case), 10195327007126 (unit), Lot Numbers: 22BBY253, 22DBG793, 22EBM485, 22GBY046, 22JBQ585, 22LBJ398, 23CBG974; e) REF DYKE1648I, UDI/DI 40195327351541 (case), 10195327351540 (unit), Lot Numbers: DYKE1648I; f) REF DYNDC3184, UDI/DI 40195327034093 (case), 10195327034092 (unit), Lot Numbers: DYNDC3184; g) REF DYNDC2842, UDI/DI 40193489342568 (case), 10193489342567 (unit), Lot Numbers: DYNDC2842; h) REF DYNJ54822D, UDI/DI 40195327151813 (case), 10195327151812 (unit), Lot Numbers: i) REF DYNJ904068D, UDI/DI 22DMI181, 22GMH542, 23FMG372, 23GMC127; j) REF DYNDC3192, UDI/DI 40195327153251 (case), 10195327153250 (unit), Lot Numbers: 23BMF718, 23CME669, 23FMJ514, 23GMH712, 23IMA898; k) REF DM1165, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: DYNDC3192; l) REF DM1165B, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: 23BBA069, 23CBR900, 23DBR127, 23EBP048, 23GBF718, 23HBN448, 23JBB725, 23JBP425; m) REF CDS984289K, UDI/DI 40195327067244 (case), 10195327067243 (unit), Lot Numbers: 22FBX071, 22JBT625, 22LBQ630, 22OBI364, 23ABP719, 23CBI370, 23FBP065, 23FBV540; n) REF DYNJ46785C, UDI/DI 40888277789389 (case), 10888277789388 (unit), Lot Numbers: 22CBY383, 22HBI240, 22JBS870, 22LBR066, 23ABC131, 23BBJ268, 23BBK356, 23CBS913; o) REF DYNDA2212B, UDI/DI 20193489197386 (case), 10193489197389 (unit), Lot Numbers: 22ILA769, 22LLA799, 23BLB093, 23ELA493; p) REF DYNJ44087B, UDI/DI 40195327346585 (case), 10195327346584 (unit), Lot Numbers: 23BBR837, 23EBF536, 23FBL664, 23HBQ739, 23IBF826, 23JBR527, 23KBA577; q) REF DYNJ907554A, UDI/DI 40195327024636 (case), 10195327024635 (unit), Lot Numbers: DYNJ907554A; r) REF DYNJ907554C, UDI/DI 40195327183838 (case), 10195327183837 (unit), Lot Numbers: 22IBF009, 22IBF810, 23ABS408, 23DBE286
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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