[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1057-2026.
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) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) P
- 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 (20)
- Medline kit SKU DYKS1378B
- UDI/DI 10195327521660 (EA) 40195327521661 (CS)
- Lot Number 25HBB410
- Medline kit SKU DYKS1448B
- UDI/DI 10195327691349 (EA) 40195327691340 (CS)
- Lot Number 25HBE055
- Medline kit SKU DYKS1163G
- UDI/DI 10195327503185 (EA) 40195327503186 (CS)
- Lot Number 25HBF057
- Medline kit SKU DYKS1487I
- UDI/DI 10198459415678 (EA) 40198459415679 (CS)
- Lot Number 25HBI512
- Medline kit SKU DYKS2056A
- UDI/DI 10198459467493 (EA) 40198459467494 (CS)
- Lot Number 25HBK906
- Medline kit SKU DYKS2074
- UDI/DI 10198459399893 (EA) 40198459399894 (CS)
- Lot Number 25HBV987
- Medline kit SKU DYKS2083
- UDI/DI 10198459435126 (EA) 40198459435127 (CS)
Distribution
Distributed nationwide across the United States.
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