[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1058-2026.
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) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS
- 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 (14)
- Medline kit SKU DYKS1339B
- UDI/DI 10195327386726(EA) 40195327386727 (CS)
- Lot Number 25HMC849
- Medline kit SKU DYKS1339C
- UDI/DI 10198459523434(EA) 40198459523435 (CS)
- Lot Number 25IMG807
- Lot Number 25JMF937
- Medline kit SKU DYKS1359B
- UDI/DI 10195327566449(EA) 40195327566440 (CS)
- Lot Number 25JMD518
- Medline kit SKU DYKS1534D
- UDI/DI 10198459310911(EA) 40198459310912 (CS)
- Lot Number 25HMD322
- Lot Number 25JMG543.
Distribution
Distributed nationwide across the United States.
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