Z-2702-2026Class II

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD...

Name: Z-2702-2026 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2026-05-11
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2026-05-11 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 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... on 2026-05-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2702-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-11
Posted: 2026-07-08
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 113,544 units (4,731 cases)
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.
Product codes and lots: Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6. UDI-DI: 00840861102556. 2. Model Number: 03-5160-1. UDI-DI: 00840861102563. 3. Model Number: 03-5300-3. UDI-DI: 00840861102518. 4. Model Number: 03-5300-3C. UDI-DI: 00840861102532. 5. Model Number: 03-5350-8. UDI-DI: 00840861102525.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2702-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2702-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-08

Product code KDI

K243505Class II5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC / cleared 2025-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)