FDA (Devices) recall action 79342
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
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.
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.
Arrow International is recalling 18,124 central venous catheter kits because they lack required safety checklists and procedure notes.
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical procedure notes and checklists.
Arrow International is recalling 18,124 central venous catheter kits because they lack required clinical guidance documents. The recall is nationwide.
Arrow International is recalling 18,124 Pressure Injectable Multi-Lumen CVC Kits because they lack required clinical safety checklists.
Arrow International is recalling 18,124 percutaneous sheath introducer kits because they lack required central line insertion checklists and procedure notes.
Arrow International is recalling 18,124 central venous catheterization kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.
Arrow International is recalling 18,124 percutaneous sheath introducer kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.