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

Medline Industries, LP: Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;

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: 1,928 total Lot/code info: Medline Kit SKU DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193; Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.

UPC codes

10198459139482, 40198459139483, 10198459592591, 40198459592592

Source

Official record: FDA (Device enforcement)

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

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