Home / Recalls / Bioseal Corporation / Z-1624-2021

Z-1624-2021 Class II

Recalled by Bioseal Corporation — Placentia, CA

Recall Details

Product Type
Devices
Report Date
May 26, 2021
Initiation Date
March 23, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
580 units

Product Description

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

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.

Distribution Pattern

US: IL and MO OUS: None

Code Information

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

Other recalls by Bioseal Corporation

  • Z-1623-2021 Class II — Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: (March 23, 2021)
  • Z-1622-2021 Class II — Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: (March 23, 2021)
  • Z-2795-2020 Class II — Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Sing (August 15, 2019)
  • Z-0085-2018 Class II — Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) (October 18, 2017)