Recall Z-3186-2024 ยท FPA Set, Administration, Intravascular
Unomedical A/S
VariSoft Infusion Set, Single Use.
| Date | Sep 19, 2024 (initiated Jul 23, 2024) |
| Status | Open, Classified |
| Reason | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". |
| Root cause | Process change control |
| Action | Unomedical initially notified the consignee on 07/23/2024 via meeting and followed up with a letter via email on 07/25/2024. The notification instructed the consignee to identify and quarantine any affected product in inventory, notify customers immediately, complete and return the response form and arrange for return of affected units. |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Unomedical A/S, Nov 1, 2017 |