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: DYNJ905869G UDI-DI 10198459394577 Lot 25JBX559 DYNJ68484B UDI-DI 10198459368967 Lot 25LME889 DYNJ58305 UDI-DI 10889942843763 Lot 25KBA708 DYNJ61167G UDI-DI 10198459386671 Lots 25KBN904 25LBQ928 CVI3940A UDI-DI 10653160998976 Lot 26AME675 DYNJ45544F UDI-DI 10193489876130 Lot 25KBJ042 DYNJ83094C UDI-DI 10198459562051 Lot 25JMD330 DYNJ39682B UDI-DI 10193489769241 Lots 25KBI410 25LBI978 26BBC735 DYNJ84882 UDI-DI 10195327432324 Lot 26CBQ487 DYNJ906336F UDI-DI 10198459419959 Lots 25KBR497 26CBO946 DYNJT6003 UDI-DI 10198459531255 Lots 25JBV850 26CBC211 DYNJ46952M UDI-DI 10198459090134 Lots 25KBH401 25LBO238 DYNJ63508A UDI-DI 10193489363845 Lot 26BBC181 DYNJ908872F UDI-DI 10198459660306 Lot 26BBR620 DM1120A UDI-DI 10653160998891 Lots 25KBA425 25LBJ075 DYNJ0368525M UDI-DI 10193489820249 Lots 25KBG895 25KBG896 DYNJ911467 UDI-DI 10198459358562 Lot 25LBA393 DYNJ86972 UDI-DI 10195327694296 Lot 26CBD230 DYNJ58406B UDI-DI 10193489957228 Lot 25JBT217 DYNJ903245C UDI-DI 10889942890170 Lot 26ABG614 DYNJT5838 UDI-DI 10198459513329 Lot 25JBT808 DYNJ906888F UDI-DI 10198459194764 Lot 26AMC879 DYNJ904468C UDI-DI 10195327631413 Lot 25KBL838 DYNJ906296I UDI-DI 10198459419829 Lot 25KBN303 DYNJ54239K UDI-DI 10198459443206 Lot 25LMG373 DYNJ81474B UDI-DI 10198459100260 Lot 25JBY253 DYNJT7387 UDI-DI 10198459615924 Lot 26CBQ932 DYNJ43954B UDI-DI 10193489509168 Lot 25LMI928 DYNJ89584 UDI-DI 10198459278723 Lots 25JBS433 25LBO815 25LBP820 DYNJ83622B UDI-DI 10198459402739 Lots 25JBA251 25JBX613 DYNJ68415C UDI-
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Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.