Agency classClass IIOur severity:High FDA (Devices)·Z-1624-2021·Announced 2021-05-26

Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth

Bioseal Corporation is recalling 580 Central Line Dressing Kits 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 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 sterile medical device with a potential breach of package integrity due to fungal growth (Aspergillus penicillioides). Per the rubric, this is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II.

Plain-English summary

Bioseal Corporation is recalling 580 units of Bioseal Central Line Dressing Kits, REF: CVC009/20, containing ChloraPREP Applicator 3 mL. The affected lots are 400521, 400514, 400551, 400556, 400541, 400536, and 400558. These products were distributed in Illinois and Missouri.

The recall was initiated because the pre-op skin prep component, ChloraPrep, included within the kits may allow the growth of Aspergillus penicillioides. This growth may penetrate the packaging, resulting in a breach of package integrity. The products are sterile and intended for single use only.

Healthcare facilities and consumers who have these specific lots should stop using the products and contact Bioseal Corporation for further instructions or a return.

The recalled product

Product: Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Manufacturer: Bioseal Corporation
Category: Medical Device — Surgical Dressings
Hazard: fungal-contamination
package-integrity-breach
Affected units: 580

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 (8)

Affected Lot Numbers: 400521
400514
400551
400556
400541
400536
400536 400536
400558

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 →

Severe
Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination
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