Reported Oct 31, 2012 · Terminated
Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010,…
Sorin Group USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004
Is this the product you have?
- Gish 3/8 x 3/8" Straight Connector with Luer fitting
- Item Numbers
EC2160BEC2160S
- Lot Numbers
121010001012151000261217000138Exp
- Dates
4/16/175/31/157/31/15
- Product UsageThe 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
- Lot codes and dates
- Item Numbers
EC2160BEC2160S
- Lot Numbers
121010001012151000261217000138Exp
- Dates
4/16/175/31/157/31/15
- Item Numbers
- Amount recalled
- 1,640 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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