Insulin Infusion Sets Recalled for Incorrect Dosing Information in Instructions
Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting insulin delivery. The hazard—incorrect dosing information in the product instructions—poses a risk of insulin underdosing for diabetes patients, classified as a risk-of-harm product where no injuries have been reported.
Plain-English summary
Unomedical A/S is recalling 1,643,320 units of Autosoft 90 infusion sets (model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824) used with Tandem insulin subcutaneous infusion pumps. These infusion sets are designed to deliver insulin to patients with diabetes.
The Instructions for Use (IFU) for the product incorrectly state the insulin fill value for two sizes of cannula. This error can result in an initial insulin infusion delivering fewer units than intended.
The affected product was distributed to California. Patients using affected Autosoft 90 infusion sets should check the recall details to determine if their product is affected. Those with affected products should contact their healthcare provider or Tandem to obtain correct dosing information and guidance.
The recalled product
- Product
- Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
- Manufacturer
- Unomedical A/S
- Affected units
- 1,643,320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 05705244018129. Model 1000282
- lot numbers: 5381154 and 5381155
- Model 1002817
- lot numbers: 5372743
- 5381082
- 5381087
- 5381083
- 5381088
- 5381091
- 5381159
- 5381084
- 5381089
- 5381160
- 5381092
- 5381094
- 5381156
- 5381157
- 5381090
- 5381158
- 5372745
Distribution
Distributed in 1 state:
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