Medline Industries, LP: Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU

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 CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898; Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748; Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.

UPC codes

10198459293535, 40198459293536, 10193489494921, 40193489494922, 10198459354007, 40198459354008

Source

Official record: FDA (Device enforcement) ↗

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