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 Breast-Hernia-Port CDS-LF kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline EBSI Kit, EBSI1534, is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline C-section kits, packs and recovery kits are being recalled because they contain a recalled lot of Ferndale Laboratories 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.
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 EBSI central line, CVC/PICC/midline and dialysis dressing change kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline da Vinci Main convenience kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline central line dressing kits, PICC/CVC/midline CHG dressing kits, port-a-cath kits and vein ablation packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.
Medline convenience kits including basic packs, general laparoscopy, CVC insertion bundles and da Vinci packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.
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.
The Medline Driveline Management Kit and Port Dressing Change Kit are being recalled because they contain a recalled lot of 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 Block Tray and Indwelling Nerve Block kit are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits for ACD, ACDF, ACL and ALIF procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits for discectomy, ear, ENT and head and neck procedures are being recalled because they contain a recalled lot of Ferndale Laboratories 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 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 Add-A-Cath Arterial Insertion kit and Ped School Age PICC Dressing Tray are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits including abdominal, bariatric and laparoscopic cholecystectomy packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline convenience kits including AV fistula, endovascular, EP device and aneurysm packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline convenience kits including pacemaker, ICD, open heart and pediatric open heart packs are being recalled over 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.
The Medline Labor & Delivery C-Section convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
The Medline IV Start Kit with HubGuard is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline SMSC Pelviscopy Pack-LF is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.