Recall Z-2642-2020 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
LivaNova USA Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
| Date | Nov 18, 2019 |
| Status | Terminated |
| Reason | Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector. |
| Root cause | Packaging process control |
| Action | Affected customers were contacted by letter sent via email or by phone call on November 18th, 2019. Customers were informed that a single lot of LivaNova USA Sterile Disposable Connector item# EC2135S, lot number 1923900091, contained a 3/8 x 1/4 reducer instead of the specified 1/2 x 1/2 connector. Customers were requested to check their inventory, quarantine (and do not use) any affected devices, complete the Customer Response Form and submit the completed form by email to USFSN@livanova.com to confirm quantity of affected products in the facility. Customers were informed that affected prod |
| Quantity | 140 units |
| Distribution | Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833322 | TUBING CONNECTORS EC-2XXX SERIES Gish Biomedical, Inc., Dec 16, 1983 |