Home / Recalls / Medical Devices
Sorin Group USA, Inc. recalls Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 121510002
Recalled October 31, 2012 · FDA recall Z-0157-2013 · Sorin Group USA
Hazard
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 Class II
Units
1,640 units
Sold at
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.
Description
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.
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.
Manufacturer(s)
Sorin Group USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →