FDA Medical Device Recalls (openFDA)
Unomedical A/S: VariSoft Infusion Set, Single Use.
- Recall number
- Z-3186-2024
- Recalling firm
- Unomedical A/S
- Product
- VariSoft Infusion Set, Single Use.
- Status
- Open, Classified
- Initiated
- 2024-07-23
- Posted
- 2024-09-19
- Terminated
- not on file
- 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.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
- 510(k) numbers
- K162812
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1000477110
- Firm city
- Lejre
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28