The Recall Desk
HighFDA (Devices)·Z-0157-2013·Announced 2012-10-31

Sorin Gish Straight Connectors Recalled for Potential Fluid Leakage

Sorin Group USA is recalling specific lots of Gish straight connectors due to a molding defect that may cause fluid leaks or air entrainment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could result in patient injury (air entrainment), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Sorin Group USA, Inc. is recalling 1,640 units of Gish 3/8 x 3/8" Straight Connectors with Luer fitting. The affected item numbers are EC2160B and EC2160S, with lot numbers 1210100010, 1215100026, and 1217000138. These connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits and are distributed as sterile stand alones and bulk non-sterile.

The recall is due to a molding irregularity that gives the connectors the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. The source text notes that entrained air could result in patient injury.

The affected units were distributed nationwide 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. Users should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and contact the manufacturer for further instructions.

The recalled product

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 extracorpore
Manufacturer
Sorin Group USA, Inc.
Category
Medical Device — Connectors
Hazard
Affected units
1,640

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Item Numbers: EC2160B
  • EC2160S
  • Lot Numbers: 1210100010
  • 1215100026
  • 1217000138
  • Exp. Dates: 4/16/17
  • 5/31/15
  • 7/31/15.

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Sorin Group USA, Inc.

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