Recall Z-1810-2022 ยท FPA Set, Administration, Intravascular
Unomedical A/S
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
| Date | Sep 26, 2022 (initiated Jul 21, 2022) |
| Status | Terminated |
| Reason | 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 | 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 i |
| Quantity | 1,643,320 units |
| Distribution | Distribution was made to California. There was no government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032854 | UNOMEDICAL MONICA INFUSION SET Unomedical A/S, Oct 9, 2003 |