The Recall Desk
HighFDA (Devices)·Z-0142-2014·Announced 2013-11-13

Sorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction

Sorin Group is recalling 84 S5 Heart-Lung Machines because of a malfunction in the cardioplegia control system.

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 used during critical cardiac surgery. While the agency classification is Class II, the source text does not report any injuries or illnesses, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Sorin Group Deutschland GmbH is recalling 84 units of the S5 Heart-lung machine, also known as the Stockert S5 System. The affected devices are identified by catalogue numbers 48-30/40/50-00 and specific serial numbers listed in the recall documentation. These systems are intended for use during cardiopulmonary bypass for procedures lasting six hours or less.

The recall is being conducted due to a malfunction of the cardioplegia control. The source text does not specify the exact nature of the malfunction or any reported injuries or illnesses associated with the defect.

The affected units were distributed worldwide, including in the United States (specifically Washington, New York, Virginia, Tennessee, South Carolina, Texas, California, Colorado, Massachusetts, Wisconsin, Maryland, Alabama, North Dakota, and Puerto Rico) and internationally to Italy, Finland, Germany, Sweden, and Great Britain. Users of these devices should contact Sorin Group for instructions on how to proceed.

The recalled product

Product
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Manufacturer
Sorin Group Deutschland GmbH
Category
Medical Device — Cardiovascular
Hazard
Affected units
84

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 (20)

  • Serial Numbers: 48E00235
  • 48E00339
  • 48E00342
  • 48E01753
  • 48E02767
  • 48E02753
  • 48E02745
  • 48E02746
  • 48E02748
  • 48E02416
  • 48E01033
  • 480E1038
  • 48E01040
  • 48E01041
  • 48E01043
  • 48E01044
  • 48E01051
  • 48E02631
  • 48E01183
  • 48E02758

Distribution

Distributed in 14 states:

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