Recall Z-0157-2013— Sorin Group USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2012-09-14, terminated 2013-04-23. It names one FDA 510(k) clearance: K833322. 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.. 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..
- Recalling firm
- Sorin Group USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-14
- Terminated
- 2013-04-23
- Firm location
- Arvada, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.