| | Class 2 Recall
Gish Connector with Luer fitting |  |
| Date Posted |
October 25, 2012 |
| Recall Number |
Z-0158-2013 |
| Product |
Gish 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, 2/28/15, 3/31/15, 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 |
Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15.
|
Recalling Firm/
Manufacturer |
Sorin Group USA, Inc.
14401 W 65th Way
Arvada, Colorado 80004 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Jack Ellison
303-467-6306
|
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.
|
| 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 |
1,380 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. |
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