FDA (Devices) recall action 78319
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.
Products labeled as sterile were distributed prior to sterilization
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 Industries is recalling 190 units of pediatric elbow closed suction catheters because they were distributed before being sterilized.
Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.