Recall Z-2453-2020 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
| Date | Apr 24, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Packaging process control |
| Action | The firm sent an URGENT MEDICAL DEVICE REMOVAL letter to affected customers on 04/24/2020. The purpose of this medical device correction is to: 1. Advise the customers of the present issue and not to use the affected devices; 2. Providing information to the user on product disposal or return and replacement; 3. Inform affected customers that LivaNova will coordinate replacement for the unused products. |
| Quantity | 24 units |
| Distribution | 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.