FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline cardiac surgery kits recalled for stuck IV check valves
OTHERNationwide distribution
Stop using affected Medline cardiac kits
Medline has recalled eight models of cardiac surgery kits that contain B. Braun IV administration sets. The check valve components in these sets may become stuck in either the open or closed position, which could affect fluid delivery during surgery. No injuries have been reported.
- Check if you have one of the recalled kits by matching your SKU and lot number to the FDA notice
- Stop using any affected kits immediately
- Contact Medline or the FDA with questions about your specific units
Hazard
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Sold states
US Nationwide distribution.
Affected count
633 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2026More Medline Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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