FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline IV Administration Sets recalled for stuck check valve
What this means
Medline kits containing B. Braun IV Administration Sets have been recalled because the check valve components may get stuck in either the open or closed position. This could affect how medication or fluids flow through the IV line. No injuries have been reported, but the sets should not be used.
- Stop using Medline kit SKU DYNJ63395B (RR-LAP DONOR NEP ACCESSORY) immediately
- Check if you have lot numbers 25HLA435 or 25HLB046
- Contact Medline or your healthcare provider for a replacement or instructions
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
33 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: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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