Fresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak
Fresenius Medical Care is recalling 5008X HD/HDF Standard Blood Tubing Sets due to a heightened probability of blood leak from the Arterial Alpha Clip connection.
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 meets the criteria for a Severe rating.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 62,544 units of the 5008X HD/HDF Standard Blood Tubing Set, Part Number 03-5300-3. The recall is due to a heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment.
The affected lots are 25JR01800, 25KR01224, 25LR01001, 25NR01018, 25NR01272, 25PR01077, 25PR01219, and 25PR01220. The UDI-DI is 00840861102518. These products were distributed worldwide, including nationwide in the United States in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NY, OH, PA, TN, TX, and VA, as well as in Lithuania.
A leak during treatment may lead to blood loss and hypovolemia. Healthcare facilities and patients should stop using the affected tubing sets and contact the manufacturer for further instructions.
The recalled product
- Product
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- Hazard
- Affected units
- 62,544
Distribution
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