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U.S. Department of Health and Human Services

Class 2 Device Recall AutoSoft

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 Class 2 Device Recall AutoSoftsee related information
Date Initiated by FirmJuly 21, 2022
Date PostedSeptember 26, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1810-2022
Recall Event ID 90719
510(K)NumberK032854 
Product Classification Set, administration, intravascular - Product Code FPA
ProductAutosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Code Information 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.
Recalling Firm/
Manufacturer		 Unomedical A/S
Aaholmvej 1 - 3
OSTED
LEJRE Denmark
For Additional Information ContactMs. Stine Corfitz
45 48 16 7000
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionThe 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 Commerce1,643,320 units
DistributionDistribution was made to California. There was no government/military distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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