[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1056-2026.
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) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit
- 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 DYKM1980C
- UDI/DI 10195327608309 (EA) 40195327608300 (CS)
- Lot Number 25JBB147
- Lot Number 25KBL305
- Medline kit SKU DYKM2137B
- UDI/DI 10198459285615 (EA) 40198459285616 (CS)
- Lot Number 25HBT834
- Lot Number 25IBJ757
- Lot Number 25JBJ557
- Medline kit SKU DYKS1372C
- UDI/DI 10195327373504 (EA) 40195327373505 (CS)
- Lot Number 25JLA480
- Medline kit SKU DYNDV1691B
- UDI/DI 10195327658472 (EA) 40195327658473 (CS)
- Lot Number 25HBI335
- Lot Number 25IBE523
- Lot Number 25JBM702
- Medline kit SKU DYNDV2464A
- UDI/DI 10195327065911 (EA) 40195327065912 (CS)
- Lot Number 25IBV942.
Distribution
Distributed nationwide across the United States.
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