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FDA (Device enforcement)Recalled 2025-12-12class ii

Medline Industries, LP: 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 DYNJ5

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 236 units Lot/code info: 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.

UPC codes

10198459228995, 40198459228996, 10198459526404, 40198459526405, 10198459443138, 40198459443139, 10198459495427, 40198459495428, 10198459231339, 40198459231330, 10198459553660, 40198459553661

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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