Recall Z-1810-2022— Unomedical A/S

Name: FDA recall Z-1810-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-21

Class II · Ongoing

Class II FDA medical device recall by Unomedical A/S, initiated 2022-07-21. It names one FDA 510(k) clearance: K032854. Product: Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.. 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..

Recalling firm: Unomedical A/S
Classification: Class II
Status: Ongoing
Initiated: 2022-07-21
Firm location: LEJRE, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K032854 — UNOMEDICAL MONICA INFUSION SETUnomedical A/S·cleared 2003-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.