Fresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
Fresenius Medical Care is recalling 120 units of 5008X Standard HD Pre-Flush Blood Tubing Sets due to a heightened probability of blood leaks during treatment.
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) during medical treatment, which aligns with the 'Severe' criteria for Class II recalls with significant injury reports or risks.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 120 units of the 5008X Standard HD Pre-Flush Standard Blood Tubing Set, Part Number 03-5110-6. The affected lots are 25KR01227 and 25NR01257, with UDI-DI 00840861102556. The products were distributed worldwide, including nationwide in the United States across 22 states and in Lithuania.
The recall is being 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.
Healthcare facilities and patients who have used or are using these specific blood tubing sets should contact Fresenius Medical Care for further instructions on how to proceed.
The recalled product
- Product
- 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
- Affected units
- 120
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 25KR01227 25NR01257 UDI-DI 00840861102556
Distribution
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