Bioseal recalls central line dressing kits with ChloraPREP applicator due to potential Aspergillus penicillioides growth that could breach packaging. Affected lots include 400521, 400514, and others. Stop using immediately.
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 include a ChloraPREP applicator. The recall is because the pre-op skin prep component may allow Aspergillus penicillioides to grow and breach packaging, potentially causing contamination.
The ChloraPREP applicator in the kits may allow Aspergillus penicillioides to grow. If this mold penetrates the packaging, it could breach the sterile integrity of the kit, leading to potential contamination during medical procedures.
Healthcare professionals using central line dressing kits with the affected lot numbers. Patients receiving these kits are at risk of infection from potential contamination.
Check the lot numbers on the packaging: 400521, 400514, 400551, 400556, 400541, 400536, and others. The product is a Bioseal Central Line Dressing Kit with ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only.
Immediately discard the affected central line dressing kits with the listed lot numbers to prevent potential contamination.
The ChloraPREP applicator may allow Aspergillus penicillioides to grow, which could breach packaging and cause contamination during medical procedures.
Affected lot numbers include 400521, 400514, 400551, 400556, 400541, 400536, and others as listed in the recall notice.
Check the lot numbers on the packaging: 400521, 400514, 400551, 400556, 400541, 400536, and others. The product is a Bioseal Central Line Dressing Kit with ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only.
We’ve drafted a message you can send Bioseal to request your refund or repair — edit it as you like.
Subject: Recall Z-1624-2021 — Bioseal Bioseal Hello, I own a Bioseal that is covered by recall Z-1624-2021 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.
