Fresenius Medical Care Holdings, Inc. recalls 5008X Blood Tubing Set

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.

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Fresenius Medical Care notified consignees on about 05/11/2026 via "IMPORTANT MEDICAL DEVICE INFORMATION" letter. Consignees were informed of the issue of potential Online Port Errors and additional information to support proper connection of the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. When pushing the substitution fluid connector (SafeLineTM) into the substitution fluid port, firmly insert the substitution fluid connector until you feel resistance. Check that there is no visible gap between the ring of the connector and the module. In the case of a visible gap between the ring of the connector and the module surface, apply pressure and push the connector to close the gap before automatic closure of the substitution fluid port door. Fresenius Medical Care is assessing improvements to restore the usual handling and user experience. FMCRTG is not requesting return of any product. ***Update*** On June 29, 2026, the firm sent a follow-up letter to consignees via First Class Mail. The updated letter states the firm has initiated shipments of limited quantities of new unaffected product. Customers are instructed to preferentially use unaffected lots of the tubing sets. If the customer needs to administer treatment and there are no alternatives available, they may use the affected lots of tubing sets to provide therapy, but only if they follow the specific instructions for using these affected sets. Unaffected lots of product do not require additional effort to seat the connector into the port.

• FDA enforcement recordOfficial FDA database entry for Z-2702-2026
• FDA 510(k) clearance · K243505The device's official FDA premarket clearance record
• FDA device classification · KDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Medical Care Holdings, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.