Agency classClass IIOur severity:Severe FDA (Devices)·Z-1623-2021·Announced 2021-05-26

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: fungal-contamination
package-integrity-breach
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

Distributed in 2 states:

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 →

Same manufacturer · Bioseal Corporation

See all →

High
Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth
FDA (Devices) · 2021-05-26
High
Bioseal Central Line Dressing Kits Recalled for Mold Contamination
FDA (Devices) · 2021-05-26
Severe
Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk
FDA (Devices) · 2020-08-19
Moderate
Bioseal Custom Surgical Kits Recalled for Expired Iodine Prep Pads
FDA (Devices) · 2017-11-15

Same hazard · fungal contamination