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: DYNJ904999J UDI-DI 10195327305024 lot 26DBJ301 DYNJ907336B UDI-DI 10198459084300 lot 26DBF966 DYNJ910821A UDI-DI 10198459453359 lots 25KBH623 26BBL877 26BBM089 DYNJ81098C UDI-DI 10198459357107 lots 25JBR783 25KBD860 DYNJ911996 UDI-DI 10198459596230 lots 25LBI311 25LBV123 26ABN955 DYNJ86584B UDI-DI 10198459410604 lot 25LMH561 DYNJ905281B UDI-DI 10195327063191 lot 25KBD109 DYNJ67271A UDI-DI 10195327626822 lot 25JBV609 DYNJ904848L UDI-DI 10198459217500 lot 26DBK390 DYNJ901355J UDI-DI 10198459224775 lot 25LBK865 DYNJ908193B UDI-DI 10198459521720 lot 25LBD958 DYNJ42963M UDI-DI 10198459611834 lot 26AMB027 DYNJ52268B UDI-DI 10195327432423 lots 25LBC027 26CBA143 DYNJ908684A UDI-DI 10198459500510 lot 26AMH337 CDS983364G UDI-DI 10195327432508 lot 26BBR233 DYNJT4339 UDI-DI 10198459448720 lot 26CBC179 DYNJ908828D UDI-DI 10198459512919 lots 25KMC466 26AMG065 DYNJ903477J UDI-DI 10195327565206 lots 26AMG182 26AMG272 SYNJ10272B UDI-DI 10195327006532 lot 25LBO306 DYNJ911853 UDI-DI 10198459559372 lot 25KBI658 DYNJ58358F UDI-DI 10198459105029 lots 25JBX146 25LBP519 DYNJ0537135V UDI-DI 10195327556389 lots 25KBG081 25LBP178 26BBC915 DYNJT7544 UDI-DI 10198459631399 lots 25LBN779 DYNJ86770 UDI-DI 10195327674229 lot 25KBJ623 DYNJ48980M UDI-DI 10195327533694 lot 25LMK166 DYNJT4161 UDI-DI 10198459410741 lot 25JBA211 DYNJ53179D UDI-DI 10198459574658 lot 25LMH296 DYNJ84891 UDI-DI 10195327434151 lot 25JBT703 DYNJ58002 UDI-DI 10889942807383 lot 25LBO695 DYNJ46938L UDI-DI 10198459090103 lot 25JBS479 DYNJ63
10195327305024, 10198459084300, 10198459453359, 10198459357107, 10198459596230, 10198459410604, 10195327063191, 10195327626822, 10198459217500, 10198459224775, 10198459521720, 10198459611834, 10195327432423, 10198459500510, 10195327432508, 10198459448720, 10198459512919, 10195327565206, 10195327006532, 10198459559372, 10198459105029, 10195327556389, 10198459631399, 10195327674229, 10195327533694, 10198459410741, 10198459574658, 10195327434151, 10889942807383, 10198459090103, 10195327131449, 10198459132360, 10198459515057, 10889942754014, 10198459285868, 10195327422103, 10198459217579, 10198459206252, 10198459610226, 10198459217586
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.