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.
Medline central venous catheter insertion kits and Vantex PI CVC bundles are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline CCI Nerve Block Trays and CPNB kits are being recalled because they contain a recalled lot of Ferndale Laboratories 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.
Centurion convenience kits including dialysis catheter maintenance and dressing change trays are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline convenience kits for ACL, arthroscopy, back and paediatric procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline EBSI central line, CVC/PICC/midline and dialysis dressing change kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Femoral Block Tray is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline neurosurgery convenience kits including neuro packs, MRI DBS packs and VP shunt kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Hernia Repair Tote convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.