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: DYNJ81673B UDI-DI 10195327494728 Lot 26AMA776 DYNJ902515K UDI-DI 10195327662608 Lot 25KBO749 DYNJ904119O UDI-DI 10198459073151 Lots 26ABB899 26ABI225 26ABJ235 CDS983883J UDI-DI 10198459429798 Lot 25KBK403 DYNJ32836B UDI-DI 10195327037369 Lot 25LMF151 DYNJ910459B UDI-DI 10198459477409 Lot 26AML096 DYNJ61165G UDI-DI 10198459386701 Lots 25LBO683 26ABE316 DYNJ60095B UDI-DI 10198459413377 Lots 25KBB960 25LBO686 DYNJ82736B UDI-DI 10198459038907 Lot 25LMG794 DYNJ911160B UDI-DI 10198459398001 Lot 26AMB749 DYNJ900906L UDI-DI 10198459408526 Lot 26AMG179 DYNJ55248F UDI-DI 10195327633486 Lot 25KBA350 DYNJ69142F UDI-DI 10198459478499 Lot 25LMF407 DYNJ61475A UDI-DI 10195327605797 Lot 25JBT649 DYNJT3759 UDI-DI 10198459351037 Lot 25KBJ720 DYNJ61515I UDI-DI 10198459542992 Lot 25KBI633 DYNJT4452 UDI-DI 10198459460678 Lot 25JBR785 DYNJ37208D UDI-DI 10195327434182 Lot 25LBJ032 DYNJ905870G UDI-DI 10198459394591 Lots 25JBP623 25LBR135 DYNJ17443T UDI-DI 10195327692971 Lot 25KBJ329 DYNJ45263B UDI-DI 10193489852394 Lot 25KBH088 DYNJT4504 UDI-DI 10198459456701 Lot 25LMI354 DYNJ45664D UDI-DI 10193489898514 Lot 25KBB002 DYNJ912005 UDI-DI 10198459597121 Lot 25KBT433 DYNJ81695B UDI-DI 10198459023453 Lot 25LMJ938 DYNJ0614113C UDI-DI 10198459352539 Lot 25KBC852 DYNJ0618369V UDI-DI 10889942826599 Lot 26BBC627 CDS981184D UDI-DI 10193489324815 Lot 26AMG257 DYNJ906302F UDI-DI 10198459419850 Lot 25KBG656 DYNJ45531G UDI-DI 10195327006037 Lots 25JBR413 25LBN719 26BBD403 DYNJ908339F UDI-DI 10198459409554 Lot 25KBM9
10195327494728, 10195327662608, 10198459073151, 10198459429798, 10195327037369, 10198459477409, 10198459386701, 10198459413377, 10198459038907, 10198459398001, 10198459408526, 10195327633486, 10198459478499, 10195327605797, 10198459351037, 10198459542992, 10198459460678, 10195327434182, 10198459394591, 10195327692971, 10193489852394, 10198459456701, 10193489898514, 10198459597121, 10198459023453, 10198459352539, 10889942826599, 10193489324815, 10198459419850, 10195327006037, 10198459409554, 10195327224547, 10193489273472, 10198459419843, 10198459240218, 10889942881222, 10198459237324, 10198459254789, 10198459438745, 10198459697159
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.