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Open, Classified

VariSoft Infusion Set, Single Use.

FDA Recall Z-3186-2024 · Posted 2024-09-19

Recalling FirmUnomedical A/S
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2024-07-23

Reason for Recall

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

Firm 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.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution in the state of California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162812Unomedical 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 SetUnomedical A/S · 2017-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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