Bioseal Central Line Dressing Kits Recalled for Mold Contamination
Bioseal Corporation is recalling Central Line Dressing Kits because the ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Aspergillus penicillioides) and a breach of sterile packaging integrity, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Bioseal Corporation is recalling 1,560 units of Bioseal Central Line Dressing Kits, REF: CVC015/20, Sterile EO. The recall involves specific lot numbers including 400530, 400528, 400536, 400537, 400514, 400522, 400569, 400565, 400556, 400540, and 400562. These kits contain a ChloraPrep Applicator 3 mL.
The recall was initiated because the pre-op skin prep component, ChloraPrep, may allow the growth of Aspergillus penicillioides. This fungal growth may penetrate the packaging, resulting in a breach of package integrity. The affected products were distributed in Illinois and Missouri.
Healthcare facilities and consumers should stop using the affected kits and contact Bioseal Corporation for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
- Manufacturer
- Bioseal Corporation
- Affected units
- 1,560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Affected Lot Numbers: 400530 400528
- 400536
- 400537
- 400514
- 400522
- 400569
- 400565
- 400556
- 400540
- 400562
- 400530
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bioseal Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Bioseal Corporation
See all →- SevereBioseal Chest Tube Insertion Tray Recalled for Mold Contamination
FDA (Devices) · 2021-05-26
- HighBioseal Central Line Dressing Kits Recalled for Potential Mold Growth
FDA (Devices) · 2021-05-26
- SevereBioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk
FDA (Devices) · 2020-08-19
- ModerateBioseal Custom Surgical Kits Recalled for Expired Iodine Prep Pads
FDA (Devices) · 2017-11-15
Same hazard · mold contamination
See all →- CriticalAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-30
- SevereAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-23
- HighTurmeric capsules recalled over mold contamination in raw material lots
FDA (Food) · 2026-02-04
- HighPariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination
FDA (Food) · 2024-08-21
- ModeratePariva Marinated Labneh Bites Recalled for Potential Mold Contamination
FDA (Food) · 2024-08-21
Similar recalls
- SevereMedical Action Industries Recalls Central Line Dressing Change Kits
FDA (Devices) · 2021-05-19
- HighMedline Convenience Kits Recalled Due to Potential Packaging Seal Defects
FDA (Devices) · 2026-09-09
- CriticalAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-30
- HighMedline Convenience Kits Recalled for Potential ChloraPrep Applicator Contamination
FDA (Devices) · 2026-09-09
- HighBlood Culture Kits Recalled Due to Potential Sterile Barrier Compromise
FDA (Devices) · 2026-09-23
- SevereAdult Chest Tube Tray Recalled Due to Package Integrity Risk
FDA (Devices) · 2021-06-16