Bioseal recalls central line dressing kits with ChloraPREP applicator that may allow Aspergillus penicillioides growth, risking package breaches. Affected lots include 400530, 400528, and others.
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.
Bioseal is recalling central line dressing kits that contain a pre-op skin prep component. This component may allow a mold called Aspergillus penicillioides to grow, potentially breaching the packaging and causing contamination.
The ChloraPREP applicator in the kit may allow Aspergillus penicillioides mold to grow. If this mold penetrates the packaging, it could breach the sterile integrity of the kit, potentially contaminating the skin prep area during medical procedures.
Healthcare professionals using Bioseal Central Line Dressing Kits with the affected lot numbers are most at risk. Patients receiving these kits during procedures could be exposed to mold if the packaging breaches.
Check the lot numbers on the Bioseal Central Line Dressing Kit packaging. Affected lots include 400530, 400528, 400537, and others listed in the recall notice.
Look for the lot numbers on the packaging to see if they match the affected lots listed in the recall.
The recall states that the ChloraPREP applicator may allow mold growth, so it is not safe to use the affected kits without checking the lot numbers.
The recall does not specify a remedy, so you should check the lot numbers and contact Bioseal if you have the affected lots.
Check the lot numbers on the packaging; affected lots include 400530, 400528, 400537, and others listed in the recall notice.
We’ve drafted a message you can send Bioseal to request your refund or repair — edit it as you like.
Subject: Recall Z-1622-2021 — Bioseal Bioseal Hello, I own a Bioseal that is covered by recall Z-1622-2021 from Bioseal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
