Recall Z-0157-2013 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Sorin Group USA, Inc.
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.
| Date | Oct 25, 2012 (initiated Sep 14, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833322 | TUBING CONNECTORS EC-2XXX SERIES Gish Biomedical, Inc., Dec 16, 1983 |