CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report
Central Line Dressing Kit, containing ChloraPREP Applicator recalled
Bioseal is recalling Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator, distributed in Illinois, Missouri. The recall was initiated on 23 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1624-2021
- FDA event ID
- 87636
- Recalling firm
- Bioseal, Placentia, CA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 23 Mar 2021
- FDA classified
- 20 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Mar 2021 | Recall initiated by company | |
| 20 May 2021 | Classified by FDA | +58 days |
| 26 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Where it was distributed
US: IL and MO OUS: None
Questions about this recall
Is Central Line Dressing Kit, containing ChloraPREP Applicator recalled?
Yes. Bioseal recalled Central Line Dressing Kit, containing ChloraPREP Applicator on 23 Mar 2021. The recall is Class II and its status is Completed. Recall number Z-1624-2021.
Why was it 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.
Which lots are affected?
Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558
Where was it sold?
US: IL and MO OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bioseal
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chest Tube Insertion Tray, containing ChloraPREP Applicator recalled | Bioseal | Sterility | IL, MO |
| Device | CLASS II | Central Line Dressing Kit, containing ChloraPREP Applicator recalled | Bioseal | Sterility | IL, MO |
| Device | CLASS II | Trachea Extender 1/pl/Cs recalled by Bioseal | Bioseal | Sterility | Nationwide |
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