Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
Reason for recall: Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment. Distribution: US Nationwide distribution. Quantity: 115,465 cases (230,930 units) Lot/code info: a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309. b. UDI-DI number: M535RFP4010. Device Catalog Number RFP-401. Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390. c. UDI-DI number: M535RFP4020. Device Catalog Number RFP-402. Lot Numbers: Q2407213, Q2407214. d. UDI-DI number: M535RFP4030. Device Catalog Number RFP-403. Lot Number: Q2407311. e. UDI-DI number: M535RFP4040. Device Catalog Number RFP-404. Lot Numbers: Q2407062, Q2407063, Q2407064, Q2407065, Q2407067, Q2407068, Q2407069, Q2407070, Q2407071, Q2407217, Q2407218, Q2407219, Q2407220, Q2407221, Q2407222, Q2407223, Q2407224, Q2407225, Q2407301, Q2407302, Q2407303, Q2407304, Q2407305, Q2407306, Q2407391, Q2407392, Q2407405, Q2407406. f. UDI-DI number: M535RFP4060. Device Catalog Number RFP-406. Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407312. g. UDI-DI number: M535RFP4530. Device Catalog Number RFP-453. Lot Number: Q2407066. h. UDI-DI number: M535RFP4540. Device Catalog Number RFP-454. Lot Numbers: Q2407145, Q2407146, Q2407226. j. UDI-DI number: M535RFP4560. Device Catalog Number RFP-456. Lot Numbers: Q2407138, Q2407139, Q2407142, Q2407143, Q2407144, Q2407227.
Official record: FDA (Device enforcement) ↗
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