Medline Industries, LP: Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- 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.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2025-11-26
- Code info
- Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843; Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327; Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.
- Product quantity
- 32 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98154
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