Fresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
Fresenius Medical Care is recalling 18,600 units of 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 meets the criteria for a Severe rating.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 18,600 units of the 5008X HD/HDF with CLiC Blood Tubing Set, part number 03-5300-3C. The recall involves specific lots identified by codes 25JR01801, 25KR01225, 25KR01251, 25NR01016, and 25NR01265, with UDI-DI 00840861102532.
The recall was issued 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.
The affected products were distributed worldwide, including nationwide distribution 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 the country of Lithuania. Healthcare facilities and consumers should stop using the affected tubing sets and contact the manufacturer for further instructions.
The recalled product
- Product
- 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
- Hazard
- Affected units
- 18,600
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 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
Distribution
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