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: DYNDC3525 UDI-DI 10198459576294 Lot 25KBM985 DT13191A UDI-DI 10653160998914 Lot 26AMA168 CDS982047S UDI-DI 10198459385735 Lot 26AMB202 DYNJ62889C UDI-DI 10198459416453 Lot 26AMA584
10198459576294, 10653160998914, 10198459385735, 10198459416453
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.