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Recall Observatory FDA recall evidence

Device product

Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

Z-1623-2021

March 23, 2021

Class II

Product summary

Firm
Bioseal Corporation
Event
Event 87636
Status
Completed
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-1623-2021

Official wording

Reason: 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.

Code information: Affected Lot Numbers: 400566, 400561, 400548, 400528

Distribution pattern: US: IL and MO OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.