Z-2452-2020 Class II Terminated
FDA device recall Z-2452-2020 was initiated by LivaNova USA Inc. on Apr 24, 2020 and is designated Class II. 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… The recall status is terminated (terminated Feb 17, 2022). Affected quantity: 96 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 8, 2020
- Initiation Date
- Apr 24, 2020
- Termination Date
- Feb 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 units
Product Description
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
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.
Distribution Pattern
US - 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, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
Code Information
LOT 2003400083
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2452-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026