Reported May 26, 2021 · Completed
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only,…
Bioseal Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bioseal Corporation · 167 W Orangethorpe Ave · Placentia, CA · 92870-6922
Is this the product you have?
- Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL
- REFCHT017/20, Sterile EO, Single Use Only
- UDI(01)10630094820177
- Lot codes and dates
- Affected Lot Numbers
400566400561400548400528
- Affected Lot Numbers
- Amount recalled
- 140 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Bioseal Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.