Z-1810-2022Class II

Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and...

Name: Z-1810-2022 Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and...
Creator: Unomedical A/S
Published: 2022-07-21
License: https://open.fda.gov/license/

Unomedical A/S / initiated 2022-07-21 / Terminated / root cause: labeling and UDI

FDA source

Unomedical A/S began a recall of Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin... on 2022-07-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1810-2022
Classification: Class II
Status: Terminated
Initiated: 2022-07-21
Posted: 2022-09-26
Terminated: 2026-05-04
Recalling firm: Unomedical A/S
Product: Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 1,643,320 units
Distribution: Distribution was made to California. There was no government/military distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1810-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1810-2022	Class II	Terminated	Voluntary: Firm initiated	2022-10-05	2022-09-26

Product code FPA

K032854Class IIUnomedical Monica Infusion SetUnomedical A/S / cleared 2003-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)