Unomedical As
Summary
- Total Recalls
- 13 (3 Class I)
- 510(k) Clearances
- 22
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3186-2024 | Class II | VariSoft Infusion Set, Single Use. | July 23, 2024 |
| Z-1544-2024 | Class II | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | March 5, 2024 |
| 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, 1002822, 1002823, a | July 21, 2022 |
| Z-1821-2015 | Class II | Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combinatio | May 21, 2015 |
| Z-0359-2017 | Class II | Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette P | November 7, 2014 |
| Z-0355-2017 | Class II | Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion | November 7, 2014 |
| Z-0356-2017 | Class II | Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion | 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 10 pcs; AC TenderLin | November 7, 2014 |
| Z-0360-2017 | Class II | SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' Su | 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 Pack w/60cm Tube & 17mm | November 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K210544 | Medtronic Extended infusion set | July 16, 2021 |
| K192647 | neria guard Infusion Set | December 13, 2019 |
| K173879 | MiniMed Mio Advance infusion set | March 5, 2018 |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Un | November 1, 2017 |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | August 10, 2016 |
| K132142 | NERIA SOFT 90 INFUSION SET | October 8, 2013 |
| K120337 | I-PORT ADVANCE INJECTION PORT | February 16, 2012 |
| K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS | April 4, 2007 |
| K061374 | INTUITION INFUSION SETS | July 31, 2006 |
| K051264 | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS | September 1, 2005 |
| K041545 | CONTACT DETACH | June 30, 2004 |
| K040633 | CLICK-ON | April 1, 2004 |
| K032854 | UNOMEDICAL MONICA INFUSION SET | October 9, 2003 |
| K973076 | EUROMEDICAL HAEMATURIA FOLEY CATHETER | September 16, 1998 |
| K962389 | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE | November 21, 1996 |
| K954751 | SILICONE ENDOTRACHEAL TUBE | December 8, 1995 |
| K954750 | PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE | December 8, 1995 |
| K954754 | WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE | December 8, 1995 |
| K954753 | PEDIATRIC SILICONE ENDOTRACHEAL TUBE | December 8, 1995 |
| K951697 | PEDIATRIC ENDOTRACHEAL TUBE | May 22, 1995 |