Z-2461-2020Class II

1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315

Name: Z-2461-2020 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Creator: LivaNova USA Inc.
Published: 2020-04-24
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2020-04-24 / Terminated / root cause: packaging

FDA source

LivaNova USA Inc. began a recall of 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 on 2020-04-24. FDA classified it as Class II and gives the reason as "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...". 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-2461-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-24
Posted: 2020-06-26
Terminated: 2022-02-17
Recalling firm: LivaNova USA, Inc.
Product: 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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.
Root cause tag: packaging
FDA 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 in commerce: 420 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)
Product codes and lots: LOT 2004900016; 2002800193

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2461-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2443-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2444-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2445-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2446-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2447-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2448-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2449-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2450-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2451-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2452-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2453-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2454-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2455-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2456-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2457-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2458-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2459-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2460-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2461-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2462-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2463-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2464-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)