[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1060-2026.
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) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE
- 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 (15)
- Medline kit SKU DYNJ0395085V
- UDI/DI 10198459313745 (EA) 40198459313746 (CS)
- Lot Number 25HMC337
- Medline kit SKU DYNJ66311C
- UDI/DI 10198459364556 (EA) 40198459364557 (CS)
- Lot Number 25KBG419
- Medline kit SKU DYNJ86770
- UDI/DI 10195327674229 (EA) 40195327674220 (CS)
- Lot Number 25IBU284
- Lot Number 25KBJ623
- Medline kit SKU DYNJ909643F
- UDI/DI 10198459392603 (EA) 40198459392604 (CS)
- Lot Number 25HBU964
- Lot Number 25IBV819
- Lot Number 25KBF028.
Distribution
Distributed nationwide across the United States.
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