FDA (Devices) recall action 87636
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.
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
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.
Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.
Bioseal Corporation is recalling 580 Central Line Dressing Kits because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.
Bioseal Corporation is recalling Central Line Dressing Kits because the ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.