NxStage Medical Inc: 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

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution. Quantity: 1316936 units Lot/code info: 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 Q22114

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.