Recall Z-2448-2020— LivaNova USA Inc.

Name: FDA recall Z-2448-2020
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: Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252. Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period..

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

Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252

Reason for recall

The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

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