FDA (Devices) recall action 84837
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
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.
Medtronic is recalling six Simulus 850 Semi Rigid Ring/Band Accessory Kits because demonstration units may have contacted porcine tissue.
Medtronic CoreValve LLC is recalling six Simulus 750 Flexible Ring/Band Accessory Kits because demonstration units may have contacted non-human tissue.