[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1051-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed nationwide across the United States.
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