Class 2 Device Recall NxStage PureFlowB

• Date Initiated by Firm: May 14, 2024
• Date Posted: June 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2160-2024
• Recall Event ID: 94641
• 510(K)Number: K053286
• Product Classification: Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
• Product: 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
• Code Information: 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 Q2311491 Q2311496 Q2311493 Q2311414 Q2311407 Q2311418 Q2311492 Q2311417 Q2311410 Q2312715 Q2312713 Q2312714 Q2312643 Q2312642 Q2401148 Q2401185 Q2401077 Q2401074 Q2401146 Q2401145 Q2401075 Q2401147 Q2401018 Q2401149 Q2401076 Q2401017 Q2401073 Q2401186 Q2402596 Q2402448 Q2402395 Q2402453 Q2402450 Q2402404 Q2402625 Q2402402 Q2402403 Q2402626 Q2402400 Q2402545 Q2402401 Q2402452 Q2402624 Q2402623 Q2402449 Q2402397 Q2402398 Q2402399 Q2402396 Q2403766 Q2403786 Q2403768 Q2403765 Q2403763 Q2403764 Q2403762; RFP-402 Lot Numbers: Q2211349 Q2211236 Q2211327 Q2211548 Q2304102 Q2304103 Q2304104 Q2305589 Q2305591 Q2305590 Q2310111 Q2311566 Q2312575; RFP-403 Lot Numbers: Q2211326 Q2310197 Q2311419 Q2311420; RFP-404 Lot Numbers: Q2211389 Q2211549 Q2211391 Q2211393 Q2211310 Q2211232 Q2211233 Q2211390 Q2211229 Q2211311 Q2211230 Q2211228 Q2211392 Q2211231 Q2212626 Q2212627 Q2301372 Q2301109 Q2301110 Q2301100 Q2301250 Q2301112 Q2301241 Q2301187 Q2301098 Q2301254 Q2301243 Q2301251 Q2301188 Q2301252 Q2301111 Q2301099 Q2301102 Q2301368 Q2301371 Q2301367 Q2301369 Q2301366 Q2301370 Q2301242 Q2301101 Q2301253 Q2302603 Q2302608 Q2302533 Q2302702 Q2302528 Q2302610 Q2302604 Q2302701 Q2302613 Q2302606 Q2302403 Q2302531 Q2302611 Q2302605 Q2302612 Q2302404 Q2302530 Q2302529 Q2302527 Q2302607 Q2302614 Q2302700 Q2302609 Q2302402 Q2302532 Q2303033 Q2303793 Q2303794 Q2303889 Q2303798 Q2303792 Q2303028 Q2303797 Q2303032 Q2303795 Q2303796 Q2303884 Q2303029 Q2303791 Q2303026 Q2303888 Q2303885 Q2303886 Q2303883 Q2303027 Q2303031 Q2303887 Q2303030 Q2304117 Q2304188 Q2304194 Q2304196 Q2304187 Q2304195 Q2305343 Q2305345 Q2305506 Q2305342 Q2305593 Q2305507 Q2305504 Q2305592 Q2305501 Q2305505 Q2305674 Q2305344 Q2305346 Q2305676 Q2305503 Q2305502 Q2305675 Q2306843 Q2306842 Q2306841 Q2307062 Q2307065 Q2307283 Q2307064 Q2307063 Q2307284 Q2308566 Q2308565 Q2308429 Q2308362 Q2308564 Q2308567 Q2308363 Q2308568 Q2308571 Q2308430 Q2308572 Q2308569 Q2308570 Q2309873 Q2309725 Q2309874 Q2309724 Q2309723 Q2309722 Q2310190 Q2310961 Q2310185 Q2310106 Q2310963 Q2310107 Q2310962 Q2310193 Q2310108 Q2310184 Q2310109 Q2310186 Q2310189 Q2310187 Q2310965 Q2310191 Q2310192 Q2310964 Q2310194 Q2310188 Q2311261 Q2311335 Q2311262 Q2311265 Q2311268 Q2311264 Q2311338 Q2311263 Q2311337 Q2311267 Q2311336 Q2311339 Q2311340 Q2311266 Q2312639 Q2312801 Q2312634 Q2312800 Q2312640 Q2312636 Q2312637 Q2312635 Q2312638 Q2401301 Q2401014 Q2401306 Q2401231 Q2401223 Q2401228 Q2401229 Q2401224 Q2401015 Q2401230 Q2401305 Q2401225 Q2401303 Q2401300 Q2401233 Q2401232 Q2401227 Q2401304 Q2401013 Q2401226 Q2401302 Q2401016 Q2402311 Q2402309 Q2402307 Q2402313 Q2402536 Q2402538 Q2402685 Q2402534 Q2402686 Q2402312 Q2402533; RFP-406 Lot Numbers: Q2211483 Q2211482 Q2211544 Q2211545 Q2301186 Q2301185 Q2301183 Q2301184 Q2302472 Q2302534 Q2302535 Q2302473 Q2303034 Q2303959 Q2303960 Q2303035 Q2303036 Q2303037 Q2304299 Q2304197 Q2306753 Q2306754 Q2306752 Q2306755 Q2306756 Q2308428 Q2309736 Q2309734 Q2309735 Q2310195 Q2310196 Q2310257 Q2401078 Q2401079; RFP-453 Lot Numbers: Q2211543 Q2310112 Q2311343 Q2311342 Q2311341 Q2312712 Q2401266; RFP-454 Lot Numbers: Q2211542 Q2211408 Q2211407 Q2310110 Q2311498 Q2311520 Q2311521 Q2311499 Q2312719 Q2312717 Q2312716 Q2312720; RFP-456 Lot Numbers: Q2308361 Q2308360 Q2309680 Q2309877 Q2309679 Q2309875 Q2309876 Q2310034 Q2310035 Q2310254 Q2312641 Q2311344 Q2311489 Q2311522
• FEI Number: 3003464075
• Recalling Firm/ Manufacturer: NxStage Medical Inc; 350 Merrimack St; Lawrence MA 01843-1748
• For Additional Information Contact: NxStage Customer Servic; 866-697-8243
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE RECALL dated 5/14/24 was sent to customers. Action to be taken by Customers 1. Check all boxes in your Pureflow B solution inventory. If you find any boxes or individual bags of Pureflow B solution from the affected lots, separate them from your other inventory and do not use them. (Refer to Appendix B for how to locate lot number). 2. Follow the instructions on the attached reply form to acknowledge your receipt of this notice. 3. Contact NxStage Customer Service (acuteorders@freseniusmedicalcare.com) to arrange for the return of all affected product. We understand that dialysis fluids are critical to patient care, and immediately removing these fluids from your facility may result in the inability to treat critically ill patients. If no alternatives are available, use of PPE (goggles) and activation of bags away from patients and other personnel will limit possibility of injury due to exposure to the fluid from the small chamber. Action to be taken by NxStage NxStage is sending this notice to all facilities that have received affected RFP-4XX to alert you of the issue and request return of the Product. As a result of this action, we expect a temporary shortage of some low volume formulations for approximately 2 weeks. NxStage is working diligently to ensure expedited product availability by securing additional supply via multiple channels If you have any questions or comments, please contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).
• Quantity in Commerce: 1316936 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPO