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.
Enforcement
- Recall Number
- Z-0158-2013
- Event ID
- 63361
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Sorin Group USA, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 31, 2012
- Initiation Date
- September 14, 2012
- Classification Date
- October 25, 2012
- Termination Date
- April 23, 2013
- Address
- 14401 W 65th Way, N/A, Arvada, CO, 80004, United States
Description
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.
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.
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.
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.
1,380 units