Z-2642-2020Class III

LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

Name: Z-2642-2020 LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Creator: LivaNova USA Inc.
Published: 2019-11-18
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2019-11-18 / Terminated / root cause: packaging

FDA source

LivaNova USA Inc. began a recall of LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case on 2019-11-18. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2642-2020
Classification: Class III
Status: Terminated
Initiated: 2019-11-18
Posted: 2020-07-17
Terminated: 2021-08-19
Recalling firm: LivaNova USA, Inc.
Product: LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: 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 tag: packaging
FDA 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 [email protected] to confirm quantity of affected products in the facility. Customers were informed that affected product should be returned to LivaNova, and that their LivaNova reference person would contact customers to organize the replacement of the affected products. Customers were informed that no patient injuries have been reported and that the event is unlikely to cause any harm to the patient or user. Customers were requested to ensure that this Medical Device Correction notice is communicated to all personnel within their organization who need to be aware of it, and, if a customer has transferred any of the affected devices to a third party, to please communicate this information to them and inform the LivaNova Quality Assurance Team at [email protected]. Customers with questions may contact LivaNova at (800) 986-4702 or by e-mail to [email protected]. Customers were informed that this action is being reported to the Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product may be reported to LivaNova at [email protected] or the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 140 units
Distribution: Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
Product codes and lots: Item# EC2135S, Lot No. 1923900091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2642-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2642-2020	Class III	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-17

Product code DTL

K833322Class IITubing Connectors Ec-2Xxx SeriesGish Biomedical, Inc. / cleared 1983-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)