Autosoft90 recallZ-1810-2022 · Unomedical A/S · initiated Jul 21, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Unomedical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
FDA root cause category: Labeling Change Control
What the company is doing
The recalling firm issued letters dated 21 July 2022 on the same day via email. The letter was to the attention of distributors and end users/consumers, but the recalling firm issued the letter only to the distributor. The letter provided a description of the problem, risk to health, and actions to be taken. The actions listed were to immediately examine their inventory and quarantine the product lots listed in the attached list. The enclosed response form was to be completed and returned by email no later than 28-Jul-2022. If the product has been further distributed, the distributor is to identify their customers and notify them of the product correction using the patient letter provided. The distributor will also be sending health care providers a Unomedical notification to make the HCP aware that all patients who may be using the Autosoft 90 infusion set models will be notified of the error in the IFU.
Recall details
- Recall number
- Z-1810-2022
- Status
- Terminated
- Initiated by the company
- Jul 21, 2022
- Posted by the FDA
- Sep 26, 2022
- Recalling firm
- Unomedical A/S
- Quantity
- 1,643,320 units
- Product code
- FPA
- FDA submissions
- K032854
- Distribution
- Distribution was made to California. There was no government/military distribution.
Product description
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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, 5381085, 5381093, 5381086, 5381101,5372744, 5381095, 5381096, 5381097, 5381099, 5381098, 5381100, 5381162, 5381107, 5381103, 5381102, 5381104, 5381108, 5381164, 5381105, 5381109, 5381161, 5381163, 5381166, 5381106, 5381165, 5381169, 5381168, 5381172, 5381167, 5381170, 5381171, 5381173, 5381178, 5381175, 5381179, 5381180, 5381176, 5381174, 5381177, 5381181, 5381182, 5381183, 5381184, 5381186, 5381189, 5381197, 5381190, 5381192, and 5381194; Model 1002818, lot numbers: 5381110, 5381111, 5381112, 5381113, and 5381200; Model 1002819, lot numbers: 5372758, 5381114, 5372759, 5381115, 5372756, 5381117, 5381118, 5381121, 5381116, 5381120, 5381122, 5381205, 5381208, 5381202, 5381119, 5381204, 5381203, 5381207, 5381206, and 5381209. Model 1002820, lot numbers: 5372762, 5381123, 5381124, 5383835, 5381125, and 5381215; Model 1002821, lot numbers: 5381126, 5381127, 5381128, 5381129, 5381130, 5381133, 5381134, 5381132, 5381131, 5381218, 5381223, 5381219, 5381221, 5381220, 5381222, and 5381224; Model 1002822, lot numbers: 5381135, 5381136, and 5381228. Model 1002823, lot numbers: 5381139, 5381137, 5381138, 5381140, 5381141, 5381142, 5381144, 5381145, 5381146, 5381147, 5381143, 5381148, 5381149, 5381230, 5381229, 5381232, 5381231, 5381233, 5381234, 5381235, and 5381238; and Model, 1002824, lot numbers: 5376469 and 5381243.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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