Recall Z-2459-2020— LivaNova USA Inc.

Name: FDA recall Z-2459-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-24

Class II · Terminated

Class II FDA medical device recall by LivaNova USA Inc., initiated 2020-04-24, terminated 2022-02-17. It names one FDA 510(k) clearance: K833322. Product: 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285. Reason: XXX.

Recalling firm: LivaNova USA Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-04-24
Terminated: 2022-02-17
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K833322 — TUBING CONNECTORS EC-2XXX SERIESGish Biomedical, Inc.·cleared 1983-12-16

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

3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

Reason for recall

XXX

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