[pending] Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ2002
Pending LLM rewrite. Source: FDA_DEVICE Z-1196-2026.
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 were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO
- 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 (12)
- Medline Kit SKU DYNJ20028L: UDI/DI 10198459228995 (EA) 40198459228996 (CS)
- Lot Number 25LMA824
- Medline Kit SKU DYNJ46546M: UDI/DI 10198459526404 (EA) 40198459526405 (CS)
- Lot Number 25KMH940
- Medline Kit SKU DYNJ54396K: UDI/DI 10198459443138 (EA) 40198459443139 (CS)
- Lot Number 25KMD804
- Medline Kit SKU DYNJ59397Q: UDI/DI 10198459495427 (EA) 40198459495428 (CS)
- Lot Number 25KMC287
- Medline Kit SKU DYNJ904052L: UDI/DI 10198459231339 (EA) 40198459231330 (CS)
- Lot Number 25JDB033
- Medline Kit SKU DYNJT6428: UDI/DI 10198459553660 (EA) 40198459553661 (CS)
- Lot Number 25KMD463.
Distribution
Distributed nationwide across the United States.
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