The Recall Desk
HighFDA (Devices)·Z-1622-2021·Announced 2021-05-26

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.

What this means for you

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
Category
Medical Device — Surgical Dressings
Hazard
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

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 →

Related recalls

Same manufacturer · Bioseal Corporation

See all →

Same hazard · mold contamination

See all →