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 C-section kits, packs and recovery kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
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 and Packs are being recalled because they contain 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 Kit: Dressing Change Ped is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Block Tray and Indwelling Nerve Block kit 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 convenience kits including abdominal, bariatric and laparoscopic cholecystectomy packs 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 Labor & Delivery C-Section convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories 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.
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 including AV fistula, endovascular, EP device and aneurysm packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
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 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.
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 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.
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.
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 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 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.
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 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 breast imaging, plastics and facial procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.