medical MODERATE Updated 2026-09-09

Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X HD/HDF with CLiC Blood Tubing Set Part number 03

See all recalls from Fresenius Medical Care Renal Therapies Group, LLC →

Recalled Product

5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for 5008X HD/HDF →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Medline Industries, LP recalls Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number

2026-09-09 · The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Cardinal Health 200, LLC recalls Presource Packs Containing CliniClean Pericare Wipes within

2026-09-09 · The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

Medline Industries, LP recalls Medline Convenience Kits containing BD ChloraPrep Clear - 1m

2026-09-09 · Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Medline Industries, LP recalls Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Nu

2026-09-09 · The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.