FDA (Devices) recall action 97495
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.
Convenience kits labeled as sterile have not gone through the sterilization process.
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 88 Extremity Pack convenience kits that were labeled as sterile but never went through the sterilization process.
Medline is recalling 22 Major Pack L-F and LB Basic Custom Pack convenience kits that were labeled as sterile but never went through the sterilization process.