5008X Blood Tubing Set connection errors FDA Class II recall
Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text identifies a potential connection issue but does not report any actual illnesses, injuries, or hospitalizations, making this a precautionary recall classified as Moderate per the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the 5008X Blood Tubing Set, which is used in dialysis treatment. The recall affects five model variations (Model Numbers 03-5110-6, 03-5160-1, 03-5300-3, 03-5300-3C, and 03-5350-8) manufactured after February 26, 2026. A total of 113,544 units (4,731 cases) have been distributed nationwide.
The recall is due to a potential for online port errors caused by connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. This is an FDA Class II recall.
The affected tubing sets were distributed in the following US states: AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, and VA.
Patients and healthcare providers should contact Fresenius Medical Care for further instructions regarding the recalled product.
The recalled product
- 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 St
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- connection-error
- port-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Sets manufactured after February 26
Distribution
Distributed nationwide across the United States.
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