Stop using now Medical device recall · FDA · Published March 23, 2021

Bioseal Central Line Dressing Kit Recall: Risk of Aspergillus Growth in Pre-op Prep

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1624-2021Medical device Bioseal ›

Stop using this now

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.

Take action

Contact the company

Recalling firmBioseal Corporation167 W Orangethorpe Ave · Placentia, CA 92870-6922

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/62991-bioseal-central-line-dressing-kit-recall-risk-of-aspergillus-growth.

Source Summary by GovInfoNow · govinfonow.com/recall/62991-bioseal-central-line-dressing-kit-recall-risk-of-aspergillus-growth · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1624-2021

Cite this page

“Bioseal Central Line Dressing Kit Recall: Risk of Aspergillus Growth in Pre-op Prep.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62991-bioseal-central-line-dressing-kit-recall-risk-of-aspergillus-growth. Based on FDA recall #Z-1624-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1624-2021%22&limit=1).

The FDA announced on March 23, 2021, that Bioseal Corporation voluntarily recalled its Central Line Dressing Kits containing ChloraPREP Applicators due to potential microbial contamination. The agency stated the recall is classified as Class II.

How to tell if you have it

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20
UPC: 00630094430096
Lot Numbers: 400521, 400514, 400551, 400556, 400541, 400536, 400558

The hazard

The pre-op skin prep component ChloraPrep included within the kits may allow the growth of Aspergillus penicillioides. This growth may penetrate the packaging, resulting in a breach of package integrity.

Context

GovInfoNow's records show Bioseal Corporation has two other recalls on record since October 18, 2017. On August 15, 2019, the company recalled Trachea Extenders due to a risk of breathing system leakage from stress cracks. Other recent recalls of similar products include Medline Convenience Kits Recall: Fungal Contamination Risk (August 11, 2026), Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026), and Medline Convenience Kits Recall: Risk of Skin Infection from Open Seal Applicators (July 20, 2026).

How to tell if you have this one

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.

Brand
Bioseal
Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Completed
Distribution
US: IL and MO OUS: None

Recall number	Product, codes & lots	Quantity
Z-1622-2021	Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157; Affected Lot Numbers: 400530 400528, 400536, 400537, 400514, 400522, 400514, 400514, 400522, 400514, 400569, 400569, 400565, 400569, 400565, 400556, 400556, 400556, 400540, 400562, 400537, 400530, 400537, 400530, 400537	1,560 units
Z-1623-2021	Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177; Affected Lot Numbers: 400566, 400561, 400548, 400528	140 units
Z-1624-2021	Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096; Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558	580 units

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately discard the affected central line dressing kits with the listed lot numbers to prevent potential contamination.

Where it went and when

Where it was distributed

Distributed in Illinois and Missouri.

FDA distribution: “US: IL and MO OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Missouri.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 23, 2021Firm started the recall
May 20, 2021FDA classified it Class II
May 26, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62991-bioseal-central-line-dressing-kit-recall-risk-of-aspergillus-growth">Bioseal Central Line Dressing Kit Recall: Risk of Aspergillus Growth in Pre-op Prep (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1624-2021 (March 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1624-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.