Bioseal recalls chest tube insertion trays with ChloraPrep applicators due to potential Aspergillus growth. Affected lots include 400566, 400561, 400548, 400528. Stop using if you have these lots.
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 chest tube insertion trays that include ChloraPrep skin prep applicators. The recall is because these applicators may allow Aspergillus penicillioides to grow, potentially breaching the packaging. This could pose a risk to patients during surgery.
The ChloraPrep applicators may allow Aspergillus penicillioides to grow inside the packaging. If the packaging breaches, this mold could enter the surgical site during procedures, potentially causing infections.
Healthcare professionals using Bioseal chest tube insertion trays with ChloraPrep applicators in surgical settings. Patients undergoing surgery with these trays are at risk if the applicators breach packaging.
Check the lot numbers on the tray: 400566, 400561, 400548, or 400528. The product includes a ChloraPrep applicator for skin prep before surgery.
Look for lot numbers 400566, 400561, 400548, or 400528 on the Bioseal chest tube insertion tray.
The ChloraPrep applicators may allow Aspergillus penicillioides to grow, potentially breaching the packaging and risking infection during surgery.
The recall record does not specify a remedy, so contact Bioseal directly for guidance.
The recall indicates a potential risk, so do not use if you have the affected lot numbers.
We’ve drafted a message you can send Bioseal to request your refund or repair — edit it as you like.
Subject: Recall Z-1623-2021 — Bioseal Bioseal Hello, I own a Bioseal that is covered by recall Z-1623-2021 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.
