Unomedical A/S
OSTED, LEJRE Sjaelland, DK
UNOMEDICAL A/S appears in FDA device records in OSTED, LEJRE Sjaelland, DK. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 52 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Unomedical A/S between 2003 and 2021. The busiest year on record is 2004, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210544 | Medtronic Extended infusion set | FPA | Substantially Equivalent | |
| K192647 | neria guard Infusion Set | FPA | Substantially Equivalent | |
| K173879 | MiniMed Mio Advance infusion set | FPA | Substantially Equivalent | |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set | FPA | Substantially Equivalent | |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | FPA | Substantially Equivalent | |
| K132142 | NERIA SOFT 90 INFUSION SET | FPA | Substantially Equivalent | |
| K120337 | I-PORT ADVANCE INJECTION PORT | FOZ | Substantially Equivalent | |
| K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS | FPA | Substantially Equivalent | |
| K061374 | INTUITION INFUSION SETS | FPA | Substantially Equivalent | |
| K051264 | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS | FPA | Substantially Equivalent | |
| K041545 | CONTACT DETACH | FPA | Substantially Equivalent | |
| K040633 | CLICK-ON | FPA | Substantially Equivalent | |
| K032854 | UNOMEDICAL MONICA INFUSION SET | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021545 | 1000477110 | UNOMEDICAL A/S | Aaholmvej 1 - 3, OSTED, LEJRE Sjaelland 4320 DK | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 52| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3186-2024 | VariSoft Infusion Set, Single Use. | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". | Class II | Open, Classified | |
| Z-1544-2024 | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU. | Class II | Open, Classified | |
| Z-0234-2024 | VariSoft infusion set, Model Number 1002830 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis. | Class I | Open, Classified | |
| Z-0233-2024 | VariSoft infusion set, Model Number 1002828 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis. | Class I | Open, Classified | |
| Z-0232-2024 | VariSoft infusion set, Model Number 1002827 | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis. | Class I | Open, Classified | |
| Z-1810-2022 | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump. | The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended. | Class II | Terminated | |
| Z-1821-2015 | Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication. | Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin. | Class II | Terminated | |
| Z-0360-2017 | SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin | Tubing detachment | Class II | Terminated | |
| Z-0359-2017 | Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin | Tubing detachment | Class II | Terminated | |
| Z-0358-2017 | 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 | Tubing detachment | Class II | Terminated | |
| Z-0357-2017 | AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin | Tubing detachment | Class II | Terminated | |
| Z-0356-2017 | Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin | Tubing detachment | Class II | Terminated | |
| Z-0355-2017 | Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin | Tubing detachment | Class II | Terminated | |
| Z-0072-2010 | Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733 | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0071-2010 | Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728 | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0070-2010 | Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725 | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0058-2010 | Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only: Product codes: 734-E, 734MM. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0057-2010 | Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distribution only: Product number 733-E. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0056-2010 | Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0055-2010 | Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E, | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0054-2010 | Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0053-2010 | Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E. Packaged under the name of Hospitak, McKesson. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0052-2010 | Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0051-2010 | Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated | ||
| Z-0050-2010 | Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E. | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain