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: DYNJ904900N UDI-DI 10198459504273 Lot 25LBB457 DYNJ67267B UDI-DI 10198459084331 Lot 25LBQ732 DYNJ9814630O UDI-DI 10195327587291 Lot 25LBD665 CDS983383L UDI-DI 10198459224577 Lot 25LBC092 DYNJ59397Q UDI-DI 10198459495427 Lot 25LMG049 DYNJT7315 UDI-DI 10198459620225 Lot 25LBO095 DYNJ25097I UDI-DI 10198459449550 Lot 25KBC747 DYNJ21925S UDI-DI 10195327105020 Lots 25KBD835 25LBR371 DYNJT6428 UDI-DI 10198459553660 Lot 26AMA602 DYNJ0785736M UDI-DI 10198459487149 Lot 25LMI831 SYNJ10307B UDI-DI 10195327007249 Lot 25LBE309
10198459504273, 10198459084331, 10195327587291, 10198459224577, 10198459495427, 10198459620225, 10198459449550, 10195327105020, 10198459553660, 10198459487149, 10195327007249
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.