Bioseal Corporation: Medical Device Recall in 2021 - (Recall #: Z-1622-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

Product Classification:

Class II

Date Initiated: March 23, 2021

Date Posted: May 26, 2021

Recall Number: Z-1622-2021

Event ID: 87636

Reason for Recall:

Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.

Status: Completed

Product Quantity: 1,560 units

Code Information:

Affected Lot Numbers: 400530 400528, 400536, 400537, 400514, 400522, 400514, 400514, 400522, 400514, 400569, 400569, 400565, 400569, 400565, 400556, 400556, 400556, 400540, 400562, 400537, 400530, 400537, 400530, 400537

Distribution Pattern:

US: IL and MO OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated