Recall Z-1821-2015— Unomedical As

Name: FDA recall Z-1821-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-21

Class II · Terminated

Class II FDA medical device recall by Unomedical As, initiated 2015-05-21, terminated 2017-01-23. It names one FDA 510(k) clearance: K120395. Product: Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.. Reason: Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin..

Recalling firm: Unomedical As
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Terminated: 2017-01-23
Firm location: Roskilde, Denmark

510(k) clearances named in this recall

1 on FDA's record

K120395 — NERIA MULTI SUBCUTANEOUS INFUSION SETUnomedical Devices S.A DE C.V.·cleared 2012-05-30

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

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

Reason for recall

Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.

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