FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline Deluxe Pre Op Kits recalled for stuck IV check valve components
Stop using affected Medline Pre Op Kits
Medline Deluxe Pre Op Kits containing B. Braun IV Administration Sets may have check valve components that stick in the open or closed position. This could affect the proper flow of intravenous fluids during medical procedures. The issue affects specific lot numbers distributed nationwide.
- Check if you have Medline kit SKU DYKS2034A, DYKS2006B, PHS972096014B, CDS984289O, or DYNJ903523F
- Do not use kits with lot numbers 25IBT843, 25IMA327, or 25IMI028
- Contact Medline Industries or your healthcare facility for instructions on replacement or proper disposal
- If kits were already used, inform your healthcare provider
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
32 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) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2026More Medline recalls
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