Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion
FDA device recall Z-1810-2022 · posted 2022-09-26 · Terminated
Recall details
- Recalling firm
- Unomedical A/S
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,643,320 units
- Distribution
- Distribution was made to California. There was no government/military distribution.
- Date initiated
- 2022-07-21
- Date posted
- 2022-09-26
- Date terminated
- 2026-05-04
- Location
- OSTED LEJRE, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNOMEDICAL MONICA INFUSION SET (K032854) | Unomedical A/S | 2003-10-09 |