The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0158-2013·Announced 2012-10-31

Sorin Gish Reducer Connectors Recalled for Potential Fluid Leakage

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II and involves a risk of patient injury from air entrainment, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Sorin Group USA, Inc. is recalling 1,380 units of Gish 3/8 x 1/2" Reducer Connectors with Luer fitting (Item Number EC2180S). The affected lots are 1108900099, 1119900091, 1203700129, 1208600013, and 1219200107, with expiration dates ranging from March 31, 2014, to July 31, 2015. These connectors are indicated for use in connecting flexible tubing in extracorporeal blood or fluid circuits and were distributed as sterile standalones and bulk non-sterile units.

The recall was initiated 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 products 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.

Healthcare facilities and distributors should stop using the affected connectors and contact Sorin Group USA for instructions on returning the products.

The recalled product

Product
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…
Manufacturer
Sorin Group USA, Inc.
Category
Medical Device — Surgical Connectors
Hazard
Affected units
1,380

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 (11)

  • 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.

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 →

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