FDA (Devices) recall action 98951
The FDA (Devices) publishes a recall like this one as 34 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 34 pages.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The Medline Hysterectomy Pack-LF is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Port A Cath convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Basic Eye kit and Tubal Ligation CDS kit are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline Minor Cath Lab Packs, OR Vascular Angio Packs and Port-A-Cath kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline da Vinci, general robotics and gynaecology laparoscopy convenience kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline WT LAVH Pack is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Kit: Dressing Change Ped is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline convenience kits for breast imaging, plastics and facial procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline C-Section Kits and Packs are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.