Z-0157-2013Class II

Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers...

Name: Z-0157-2013 Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers...
Creator: Sorin Group USA, Inc.
Published: 2012-09-14
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2012-09-14 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17... on 2012-09-14. FDA classified it as Class II and gives the reason as "Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0157-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Posted: 2012-10-25
Terminated: 2013-04-23
Recalling firm: LivaNova USA, Inc.
Product: Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors are distributed as sterile stand alones and bulk non-sterile.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sorin Group USA, Inc. sent a Product Recall letter to all affected customers by certified mail on September 14, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to discontinue use of the affected product, return all unused product to the firm and to complete and return a Response Form via fax or email. For further questions, contact the firm at 1-800-650-2623.
Quantity in commerce: 1,640 units
Distribution: US Nationwide Distribution in the states of: AL, AR, CA, CO, CT, FL, IL, MI, MN, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.
Product codes and lots: Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0157-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0157-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0158-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25

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)