FDA (Devices) recall action 79294
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Product packaging may not be completely sealed.
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 Inc is recalling Pneumothorax Kits because the product packaging may not be completely sealed.
Arrow International is recalling Large Volume Abdominal Paracentesis Kits because the packaging may not be completely sealed.
Arrow International Inc. is recalling PleuraSeal Thoracentesis Kits because product packaging may not be completely sealed.