Fresenius Medical Care Holdings, Inc. 5008X Blood Tubing Set recall: Potential for Online Port Errors due to connection issues when connecting
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.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: 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.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2702-2026
- Published
- July 15, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Fresenius Medical Care Holdings, Inc.
- Product type
- Medical devices
- Units affected
- 113,544 units (4,731 cases)
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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.
- UPC codes
- 00840861102556, 00840861102518, 00840861102532, 00840861102525
Products covered by this recall
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.
Check your product
The notice names 30 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00840861102556
- 00840861102518
- 00840861102532
- 00840861102525
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 26BR01184
- 26BR01202
- 26CR01025
- 26CR01039
- 26CR01803
- 26BR01185
- 26BR0
- 26CR01018
- 26CR01020
- 26DR01129
- 26DR01150
- 26CR01019
- 26CR01021
- 26DR0
- 26CR01017
- 26DR01077
- 26DR01079
- 26DR01080. — 113
- 544 units
Model or item number
On the rating label, the box or the instruction sheet.
- 03-5110-6. 2. 5008X HD
- 03-5300-3. 3. 5008X HD
- 03-5300-3C. 4. 5008X HD
- 03-5110-6
- 03-5300-3
- 03-5300-3C
- 03-5350-8
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Fresenius Medical Care Holdings, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: Fresenius Medical Care Holdings, Inc. — 920 Winter St Bld 920, Waltham, MA, 02451-1521
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Fresenius Medical Care Holdings, Inc. medical devices recalled?
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. 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.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00840861102556, 00840861102518, 00840861102532; lot code 26BR01184, 26BR01202, 26CR01025; model number 03-5110-6. 2. 5008X HD, 03-5300-3. 3. 5008X HD, 03-5300-3C. 4. 5008X HD. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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