FDA Medical Device Recalls (openFDA)
Unomedical A/S: VariSoft infusion set, Model Number 1002828
- Recall number
- Z-0233-2024
- Recalling firm
- Unomedical A/S
- Product
- VariSoft infusion set, Model Number 1002828
- Status
- Open, Classified
- Initiated
- 2023-10-11
- Posted
- 2023-11-21
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process change control
- Action
- Unomedical a/s issued an Urgent Field Safety Notice to its sole consignee on 10/11/2023 via email. The notice explained the issue, potential risk to patient, and requested the distributor to quarantine all affected product pending return and to notify their customers.
- Quantity
- 1679 units
- Distribution
- US Nationwide distribution in the state of CA.
- Lot, serial or model codes
- GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376
- 510(k) numbers
- ["K162812"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1000477110
- Firm city
- OSTED 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