Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1055-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
- 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 ACC010271B
- UDI/DI 10193489484953 (EA) 40193489484954 (CS)
- Lot number 25IDB125
- Lot number 25IDB400
- Lot number 25JDB835
- Lot number 25KDA036
- Lot number 25KDA248
- Medline kit SKU ACC010416B
- UDI/DI 10195327223670 (EA) 40195327223671 (CS)
- Lot number 25IDA545
- Lot number 25JDB867
- Medline kit SKU ACC010525C
- UDI/DI 10198459027765 (EA) 40198459027766 (CS)
- Lot number 25KDA768
- Medline kit SKU ACC010688
- UDI/DI 10195327432713 (EA) 40195327432714 (CS)
- Lot number 25HDB656
- Lot number 25IDA638
- Lot number 25JDA666
- Medline kit SKU ACC010770
Distribution
Distributed nationwide across the United States.
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