Home / Recalls / Unomedical As / Z-0358-2017

Z-0358-2017 Class II Terminated

Recalled by Unomedical As — Roskilde

Recall Details

Product Type
Devices
Report Date
November 9, 2016
Initiation Date
November 7, 2014
Termination Date
November 16, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,114 units

Product Description

Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Reason for Recall

Tubing detachment

Distribution Pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

Code Information

5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964

Other recalls by Unomedical As

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  • Z-0232-2024 Class I — VariSoft infusion set, Model Number 1002827 (October 11, 2023)
  • Z-0234-2024 Class I — VariSoft infusion set, Model Number 1002830 (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-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-0356-2017 Class II — Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6m (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)