recall
saveFresenius Medical Care Holdings, Inc. recall (Cls II)
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0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10 — Reason: Lack of Assurance of Sterility — Status: Ongoing
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same company · ±60 days · 3
- device 510kFresenius Medical Care Renal Therapies Group, LLC — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (510k cleared)Jun 13, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — 5008X Hemodialysis System (510k cleared)May 30, 2025
- device recallFresenius Medical Care Holdings, Inc. device recall (Cls II)Aug 29, 2025
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