Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item… recallZ-0157-2013 · Sorin Group USA, Inc. · initiated Sep 14, 2012
Class II Terminated All recalls posted in October 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sorin Group USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0157-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 14, 2012
- Posted by the FDA
- Oct 25, 2012
- Recalling firm
- Sorin Group USA, Inc.
- Quantity
- 1,640 units
- Product code
- DTL
- FDA submissions
- K833322
- 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 description
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.
Code information (models, lots, serial numbers)
Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15.
Other devices under the same FDA submission
1 device cleared under K833322 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ConnectorLivanova USA, Inc. · ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 63361).
- Z-0158-2013 · TerminatedGish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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