Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Reason for recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. Distribution: US Nationwide distribution. OUS distribution pending. Quantity: 49,654 kits total Lot/code info: DYNJT5893 UDI-DI 10198459517839 Lot 25KBA123 SYNJ10306A UDI-DI 10193489296891 Lots 25LBO305 26CBD081 DYNJ68023 UDI-DI 10193489468083 Lot 25KBI169 DYNJ909926C UDI-DI 10198459423109 Lots 25LBC067 25LBR659 DYNJ84081B UDI-DI 10198459462474 Lot 25LMI881 DYNJ905362C UDI-DI 10198459346842 Lots 25KBN239 25LBF694 DYNJ0660040R UDI-DI 10889942220083 Lots 25JME572 26AMA936 DYNJ89023A UDI-DI 10198459388316 Lot 25KBC500 DYNJ902510M UDI-DI 10198459683374 Lots 26CBM279 26CBO942 DYNJ84766 UDI-DI 10195327414108 Lot 26BBC049 DYNJ0578842M UDI-DI 10193489288292 Lot 25LMG027 DYNJ63803C UDI-DI 10198459149825 Lots 25LBN476 26CBC156 DYNJ62433D UDI-DI 10198459498176 Lots 25KBC752 25KBM917 DYNJ81772C UDI-DI 10198459349362 Lots 25LMH594 25LMI396 DYNJT7588 UDI-DI 10198459635182 Lot 26AMA250 DYNJ89048A UDI-DI 10198459388477 Lot 26BBD124
10198459517839, 10193489296891, 10193489468083, 10198459423109, 10198459462474, 10198459346842, 10889942220083, 10198459388316, 10198459683374, 10195327414108, 10193489288292, 10198459149825, 10198459498176, 10198459349362, 10198459635182, 10198459388477
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.