FDA Device recall Z-2457-2020
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 by Livanova Usa, citing 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 asse….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2457-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-24 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
Product
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
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.
Identifiers
| code_info | LOT 2003400088 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2025-02-12 · Livanova Usa - Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: T…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product De…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
FDA Device · Class II · 2022-02-09 · Livanova Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2457-2020%22
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