Recall Z-2453-2020— LivaNova USA Inc.
Class II · Terminated
Class II FDA medical device recall by LivaNova USA Inc., initiated 2020-04-24, terminated 2022-02-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290. 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
Product description
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
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.