Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Issued by
FDA
Distribution: Nationwide (United States)
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 DYNJ63113B UDI-DI 10195327131449 lot 25KBJ559 DYNJ69662A UDI-DI 10198459132360 lot 25JBX052 DYNJT5855 UDI-DI 10198459515057 lots 25JBV938 25LBO691 DYNJ903263B UDI-DI 10889942754014 lot 26CBQ083 DYNJ908806C UDI-DI 10198459285868 lot 25LMJ639 DYNJ902056C UDI-DI 10195327422103 lots 25JBU940 25LBR965 DYNJ904846I UDI-DI 10198459217579 lot 26CBS964 DYNJ905871F UDI-DI 10198459206252 lot 25LBA302 DYNJ906986G UDI-DI 10198459610226 lot 26AMJ169 DYNJ904847K UDI-DI 10198459217586 lot 25KBR022 DYNJ909505D UDI-DI 10198459594229 lot 25LMJ127 CDS983115K UDI-DI 10198459579608 lot 25LBE987 DYNJ905286G UDI-DI 10198459248184 lots 26AMA067 26AMH307 DYNJ58356F UDI-DI 10198459104923 lot 25LBR764 DYNJ904139L UDI-DI 10198459528583 lot 25JBT916 DYNJ63114C UDI-DI 10193489870206 lot 25JBX122 DYNJ0101088G UDI-DI 10198459619960 lot 25LBQ608 DYNJ905020J UDI-DI 10198459548314 lot 25KBJ908 DYNJ53707 UDI-DI 10889942441082 lots 25LBP985 26CBR371 DYNJT4386 UDI-DI 10198459457609 lot 25KBK189 DYNJ0565499AN UDI-DI 10195327318352 lot 25JMF339 DYNJ58706F UDI-DI 10198459124877 lot 26CBC852 DYNJ910097A UDI-DI 10198459504785 lot 26AMD592 CDS983134C UDI-DI 10195327147655 lot 25KBT474 DYNJ37202G UDI-DI 10195327685393 lots 25JBS464 25LBR525 DYNJ40221G UDI-DI 10198459448515 lot 25LMJ294 DYNJ905282C UDI-DI 10195327393069 lot 25KBM844 DYNJ58290D UDI-DI 10195327513467 lot 25LBQ039 DYNJ65484A UDI-DI 10195327303501 lot 25LMB980 DYNJ906892B UDI-DI 10198459168611 lots 25KBG661 26BBC906 DYNJ902158L UDI-DI 10198459453021 lot 25LBD928 DYNJ902158M UDI-DI 10198459681721 lot 26DBK385 DYNJ902142L UDI-DI 10198459452970 lot 25LBA949 DYNJ58259A UDI-DI 10193489734034 lots 25JBY406 25LBM865 DYNJ62288D UDI-DI 10195327605827 lots 25JBA294 25KBB258 DYNJ20509R UDI-DI 10198459277849 lots 25LMH654 26AMB105 DYNJ903250B UDI-DI 10889942755288 lot 25KBM855 DYNJ43956C UDI-DI 10193489970708 lot 25KBL821 DYNJ36331D UDI-DI 10198459416446 lot 25LMH136 DYNJ56501A UDI-DI 10195327310752 lot 25LMI162 DYNJ900893M UDI-DI 10198459408632 lots 25KMB298 26AMB284 DYNJ904184I UDI-DI 10198459640704 lot 26CBO500 DYNJ904842G UDI-DI 10198459217753 lot 25LBC835 DYNJ83483 UDI-DI 10195327268916 lot 25KBH325 DYNJ42973N UDI-DI 10198459621178 lot 26AMA642 DYNJ68399C UDI-DI 10195327341763 lot 26BBD183 DYNJ49692G UDI-DI 10195327347352 lot 26AMA587 DYNJ910451A UDI-DI 10198459365560 lot 25KBG700 26ABF330 DYNJ20147O UDI-DI 10198459377617 lot 25JBA158 DYNJ84971 UDI-DI 10195327442620 lot 26BBC185 DYNJ86044A UDI-DI 10198459404351 lot 25LBQ169 DYNJ86308C UDI-DI 10198459425233 lot 25LBQ110 DYNJ88917 UDI-DI 10198459215926 lot 25LMF333 DYNJS3069 UDI-DI 10888277058286 lot 25LBC215 DYNJT4163 UDI-DI 10198459410758 lot 26BBC139 DYNJT8396 UDI-DI 10198459704871 lot 26CBE087 DYNJ909593C UDI-DI 10198459523816 lot 25LBB787 DYNJ910906D UDI-DI 10198459472626 lot 25KBJ090 DYNJ64156B UDI-DI 10195327678746 lots 25KBC275 25LBC916 26CBC871 DYNJ904186G UDI-DI 10198459002922 lots 25KBG639 25LBB568 DYNJ60967 UDI-DI 10193489537918 lot 25LMJ893 DYNJ61409A UDI-DI 10193489778595 lots 25LMH863 26AMC051 DYNJ902528M UDI-DI 10198459445873 lot 25KBU092 DYNJ910795B UDI-DI 10198459594205 lot 25LMH707
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.