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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2160-2024

NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456

Publicado el 26 de junio de 2024 · Inicio del retiro: 14 de mayo de 2024

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

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
NxStage Medical Inc
Distribuidor
US Nationwide distribution.
Lote
Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M535RFP4010; Catalog Number: RFP-402, Primary Device Identifier: M535RFP4020; Catalog Number: RFP-403, Primary Device Identifier: M535RFP4030; Catalog Number: RFP-404, Primary Device Identifier: M535RFP4040; Catalog Number: RFP-405, Primary Device Identifier: M535RFP4050; Catalog Number: RFP-406, Primary Device Identifier: M535RFP4060; Catalog Number: RFP-453, Primary Device Identifier: M535RFP4530; Catalog Number: RFP-454, Primary Device Identifier: M535RFP4540; Catalog Number: RFP-456, Primary Device Identifier: M535RFP4560; RFP-400 Lot Numbers: Q2211552 Q2211554 Q2211553 Q2211312 Q2211551 Q2211555 Q2211313 Q2211314 Q2211556 Q2211315 Q2301381 Q2302705 Q2302703 Q2302706 Q2302704 Q2303710 Q2303737 Q2303709 Q2303790 Q2303708 Q2303707 Q2304269 Q2304267 Q2304268 Q2305365 Q2305429 Q2305366 Q2305416 Q2305594 Q2305428 Q2306919 Q2306918 Q2306834 Q2306921 Q2306833 Q2306917 Q2306996 Q2306915 Q2306920 Q2306916 Q2306922 Q2306679 Q2306832 Q2308427 Q2308425 Q2308426 Q2309805 Q2309803 Q2309798 Q2309801 Q2309804 Q2309802 Q2309800 Q2309799 Q2310032 Q2310033 Q2310031 Q2310029 Q2310030 Q2311574 Q2311570 Q2311569 Q2311572 Q2311567 Q2311573 Q2311568 Q2311571 Q2401156 Q2401151 Q2401152 Q2401157 Q2401154 Q2401155 Q2401153 Q2401150 Q2402456 Q2402428 Q2402454 Q2402628 Q2402458 Q2402630 Q2402455 Q2402627 Q2402457 Q2402429; RFP-401 Lot Numbers: Q2211399 Q2211325 Q2211402 Q2211473 Q2211470 Q2211324 Q2211316 Q2211318 Q2211395 Q2211403 Q2211484 Q2211474 Q2211317 Q2211401 Q2211323 Q2211394 Q2211398 Q2211319 Q2211472 Q2211396 Q2211406 Q2211397 Q2211479 Q2211481 Q2211404 Q2211322 Q2211546 Q2211321 Q2211405 Q2211480 Q2211471 Q2211477 Q2211476 Q2211485 Q2211320 Q2211478 Q2211475 Q2211400 Q2212628 Q2212629 Q2212630 Q2301023 Q2301373 Q2301104 Q2301105 Q2301025 Q2301244 Q2301245 Q2301024 Q2301248 Q2301376 Q2301374 Q2301026 Q2301246 Q2301175 Q2301103 Q2301182 Q2301247 Q2301179 Q2301375 Q2301178 Q2301033 Q2301249 Q2301107 Q2301181 Q2301032 Q2301106 Q2301108 Q2301029 Q2301031 Q2301176 Q2301177 Q2301030 Q2301180 Q2302452 Q2302457 Q2302519 Q2302595 Q2302600 Q2302456 Q2302517 Q2302454 Q2302524 Q2302520 Q2302602 Q2302523 Q2302453 Q2302598 Q2302450 Q2302599 Q2302518 Q2302594 Q2302451 Q2302521 Q2302596 Q2302601 Q2302401 Q2302522 Q2302597 Q2302379 Q2302400 Q2302378 Q2302455 Q2303958 Q2303803 Q2303799 Q2303881 Q2303878 Q2303951 Q2303800 Q2303882 Q2303954 Q2303955 Q2303953 Q2303802 Q2303801 Q2303880 Q2303879 Q2303877 Q2303952 Q2303804 Q2303957 Q2303876 Q2303956 Q2304114 Q2304116 Q2304115 Q2304189 Q2304270 Q2304191 Q2304271 Q2304110 Q2304277 Q2304107 Q2304272 Q2304273 Q2304108 Q2304113 Q2304192 Q2304193 Q2304105 Q2304106 Q2304276 Q2304275 Q2304190 Q2304109 Q2304274 Q2304111 Q2304112 Q2305426 Q2305595 Q2305420 Q2305417 Q2305509 Q2305418 Q2305678 Q2305508 Q2305423 Q2305419 Q2305669 Q2305348 Q2305427 Q2305597 Q2305598 Q2305677 Q2305596 Q2305421 Q2305349 Q2305424 Q2305667 Q2305670 Q2305672 Q2305671 Q2305347 Q2305351 Q2305425 Q2305668 Q2305422 Q2305673 Q2305350 Q2306751 Q2306758 Q2306749 Q2306836 Q2306835 Q2306750 Q2306757 Q2306838 Q2306998 Q2306840 Q2306997 Q2306837 Q2306839 Q2307275 Q2307278 Q2307277 Q2307276 Q2307280 Q2307279 Q2307281 Q2307282 Q2308519 Q2308432 Q2308431 Q2308595 Q2308434 Q2308594 Q2308433 Q2308520 Q2308521 Q2309646 Q2309730 Q2309878 Q2309795 Q2309887 Q2309676 Q2309732 Q2309727 Q2309733 Q2309879 Q2309729 Q2309880 Q2309886 Q2309677 Q2309885 Q2309797 Q2309678 Q2309796 Q2309647 Q2309883 Q2309881 Q2309731 Q2309649 Q2309884 Q2309648 Q2309728 Q2309882 Q2310036 Q2310037 Q2310105 Q2310100 Q2310258 Q2310103 Q2310957 Q2310104 Q2310101 Q2310098 Q2310958 Q2310966 Q2310959 Q2310027 Q2310256 Q2310028 Q2310960 Q2310099 Q2310969 Q2310102 Q2310971 Q2310255 Q2310968 Q2310989 Q2310970 Q2310988 Q2310967 Q2311408 Q2311260 Q2311259 Q2311416 Q2311406 Q2311411 Q2311490 Q2311331 Q2311495 Q2311497 Q2311409 Q2311413 Q2311334 Q2311333 Q2311494 Q2311415 Q2311412 Q2311332 Q2
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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