Fresenius Medical Care Holdings, Inc.: 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/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Recall number

Z-2702-2026

Recalling firm

Fresenius Medical Care Holdings, Inc.

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/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Status

Open, Classified

Initiated

2026-05-11

Posted

2026-07-08

Terminated

not on file

Reason

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

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 06/292026, 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. ***Update*** On 08/10/2026, the firm sent a follow up letter to consignees notifying them that product stock is available to replace affected products and the notification included specific lot numbers affected.

Quantity

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.

Lot, serial or model codes

Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6; UDI-DI: 00840861102556; Lot Number: 26BR01177. 2. Model Number: 03-5300-3; UDI-DI: 00840861102518; Lot Numbers: 26BR01184, 26BR01202, 26CR01025, 26CR01039, 26CR01803, 26BR01185, 26BR01214, 26CR01026, 26CR01040, 26CR01804, 26BR01188, 26BR01215, 26CR01027, 26CR01041, 26DR01134, 26BR01189, 26BR01805, 26CR01029, 26CR01043, 26BR01201, 26CR01003, 26CR01034, 26CR01800. 3. Model Number: 03-5300-3C; UDI-DI: 00840861102532; Lot Numbers: 26CR01018, 26CR01020, 26DR01129, 26DR01150, 26CR01019, 26CR01021, 26DR01130, 26DR01151. 4. Model Number: 03-5350-8; UDI-DI: 00840861102525; Lot Numbers: 26CR01017, 26DR01077, 26DR01079, 26DR01080.

510(k) numbers

K243505

PMA numbers

not on file

Product code

KDI

Firm FEI

3001451489

Firm city

Waltham

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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