Summary
The FDA issued a Class I for VariSoft infusion set, Model Number 1002830 by Unomedical A/S. Reason: The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing.
Details
Source
Device Recall
External ID
Z-0234-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
VariSoft infusion set, Model Number 1002830
Lot/Code Info: GTIN 05705244018792, Serial Numbers: 5388368; GTIN 05705244018785, Serial Numbers: 5388368
Quantity Affected: 3362 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-11
Company
LEJRE, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Unomedical A/S has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Unomedical A/S) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unomedical A/S have FDA actions?
Unomedical A/S has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0234-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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