Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination
Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a breach of sterile package integrity and fungal contamination, which aligns with the 'Severe' criteria for significant injury or property damage reports or high-risk structural defects.
Plain-English summary
Bioseal Corporation is recalling 140 units of the Bioseal Chest Tube Insertion Tray, REF: CHT017/20. The affected lots are 400566, 400561, 400548, and 400528. These sterile, single-use trays contain a ChloraPREP Applicator 3 mL.
The recall was initiated because the ChloraPrep component may allow the growth of Aspergillus penicillioides. This fungal growth may penetrate the packaging, resulting in a breach of package integrity. The agency has classified this as a Class II recall.
The affected products were distributed in Illinois and Missouri. No other states or countries are listed in the distribution pattern. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected trays.
The recalled product
- Product
- Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
- Manufacturer
- Bioseal Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 140
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 (4)
- Affected Lot Numbers: 400566
- 400561
- 400548
- 400528
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.
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