FDA DeviceClass IINotable
FDA Recall: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1.
Description
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Hazard
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Remedy
113,544 units (4,731 cases)
Related Recalls
2026-06-17 · FDA_DEVICE
FDA Recall: Bicarby Dialysate; Model number: RFP-400-G;
Fresenius Medical Care Holdings, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-4
Fresenius Medical Care Holdings, Inc.
2026-05-13 · FDA_DRUG
FDA Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperiton
Fresenius Medical Care Holdings, Inc.
2026-05-13 · FDA_DRUG
FDA Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperiton
Fresenius Medical Care Holdings, Inc.