Home / Recalls / Unomedical A/S / Z-3186-2024

Z-3186-2024 Class II Ongoing

Recalled by Unomedical A/S — Lejre

Recall Details

Product Type
Devices
Report Date
September 25, 2024
Initiation Date
July 23, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

VariSoft Infusion Set, Single Use.

Reason for Recall

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

Distribution Pattern

US Nationwide distribution in the state of California.

Code Information

UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241

Other recalls by Unomedical A/S

  • Z-1544-2024 Class II — Neria Soft Infusion Set, Product Code 507302, intravascular administration set (March 5, 2024)
  • Z-0234-2024 Class I — VariSoft infusion set, Model Number 1002830 (October 11, 2023)
  • Z-0232-2024 Class I — VariSoft infusion set, Model Number 1002827 (October 11, 2023)
  • Z-0233-2024 Class I — VariSoft infusion set, Model Number 1002828 (October 11, 2023)
  • Z-1810-2022 Class II — Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, (July 21, 2022)
  • Z-1821-2015 Class II — Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset (May 21, 2015)
  • Z-0359-2017 Class II — Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradi (November 7, 2014)
  • Z-0358-2017 Class II — Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pac (November 7, 2014)
  • Z-0357-2017 Class II — AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 (November 7, 2014)
  • Z-0360-2017 Class II — SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; S (November 7, 2014)