FDA (Devices) recall action 98277
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
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 is recalling 650 units because these lots of reprocessed catheters may contain small particles of residual material.
Medline is recalling 48 reprocessed St. Jude Supreme and Response diagnostic electrophysiology catheters because these lots may contain small particles of residual material.
Medline is recalling 41 reprocessed Livewire steerable diagnostic electrophysiology catheters because these lots may contain small particles of residual material.
Medline is recalling 228 units because these lots of reprocessed catheters may contain small particles of residual material.
Medline is recalling 94 units because these lots of reprocessed catheters may contain small particles of residual material.
Medline is recalling 311 units because these lots of reprocessed catheters may contain small particles of residual material.
Medline is recalling 511 reprocessed Siemens ACUSON AcuNav diagnostic ultrasound catheters because these lots may contain small particles of residual material.