FDA recall, , Moderate risk
Fresenius Medical Care 5008X Blood Tubing Sets
5008X Blood Tubing Set may have connection issues that can cause online port errors.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Medical Care Holdings, Inc., of Waltham, Massachusetts, is recalling the 5008X Blood Tubing Set, 24 units per case, because of 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 recall includes the 5008X HD Pre-Flush Standard Blood Tubing Set, 5008X HD Pre-Flush With Twister Blood Tubing Set, 5008X HD/HDF Standard Blood Tubing Set, 5008X HD/HDF With CLiC Blood Tubing Set, and 5008X HD/HDF With Twister Blood Tubing Set.
The company began the recall on May 11, 2026. The product was distributed in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia, and the District of Columbia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
03-5110-6
- UDI-DI
- 00840861102556
- 00840861102518
- 00840861102532
- 00840861102525
- Lot code
- 26BR01177
- 03-5300-3
- 26BR01184
- 26BR01202
- 26CR01025
- 26CR01039
- 26CR01803
- 26BR01185
- 26BR01214
- 26CR01026
- 26CR01040
- 26CR01804
- 26BR01188
- 26BR01215
- 26CR01027
- 26CR01041
- 26DR01134
- 26BR01189
- 26BR01805
- 26CR01029
- 26CR01043
- 26BR01201
- 26CR01003
- 26CR01034
- 26CR01800
- 03-5300-3C
- 26CR01018
- 26CR01020
- 26DR01129
- 26DR01150
- 26CR01019
- 26CR01021
- 26DR01130
- 26DR01151
- 03-5350-8
- 26CR01017
- 26DR01077
- 26DR01079
- 26DR01080
03-5160-1
03-5300-3
03-5300-3C
03-5350-8
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia.
- Company
- Fresenius Medical Care Holdings, Inc.Waltham, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99061
- Recall number
- Z-2702-2026
- Quantity recalled
- 113,544 units (4,731 cases)
All recalls from Fresenius Medical Care Holdings, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
