Fresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
Fresenius Medical Care is recalling 5008X HD/HDF blood tubing sets due to a heightened probability of blood leaks that could cause blood loss and hypovolemia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (blood loss and hypovolemia), which aligns with the 'Severe' criteria for Class II recalls with significant injury reports.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 6,624 units of the 5008X HD/HDF with Twister Blood Tubing Set, Part Number 03-5350-8. The recall involves specific lots (25JR01802, 25NR01017, 25NR01266) and UDI-DI 00840861102525. The product was distributed worldwide, including nationwide in the United States and in Lithuania.
The recall is being conducted because of a heightened probability of blood leaking from the connection between the Arterial Alpha Clip and the main line or pump segment. If a leak occurs during treatment, it may lead to blood loss and hypovolemia.
Healthcare facilities and consumers who have these specific lots of the blood tubing set should stop using the product and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Hazard
- Affected units
- 6,624
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)
- Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
Distribution
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