Z-2446-2020 Class II Terminated
FDA device recall Z-2446-2020 was initiated by LivaNova USA Inc. on April 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 February 17, 2022). Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- April 24, 2020
- Termination Date
- February 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
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 2004300003