VariSoft Infusion Set, Single Use.
This recall is currently active, issued September 19, 2024. It was issued by Unomedical A/S Osted Aholmvej 1.
- Company
- Unomedical A/S Osted Aholmvej 1
- Recall Initiated
- July 23, 2024
- Posted
- September 19, 2024
- Recall Number
- Z-3186-2024
- Official Source
- View on FDA website ↗
Reason for Recall
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Distribution
US Nationwide distribution in the state of California.
Lot / Code Info
UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Root Cause
Process change control
Action Taken
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.