The Recall Desk
HighFDA (Devices)·Z-1673-2014·Announced 2014-06-11

Bayer Medrad Continuum MR Infusion System Recall for Damaged Locking Pins

Bayer is recalling non-wireless Medrad Continuum MR Infusion Systems shipped before March 2008 due to potentially damaged locking pins in the bracket.

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 is classified as FDA Class II, and the source describes a 'potential safety risk' without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bayer Corp is recalling 1,347 units of the Medrad Continuum MR Infusion System, specifically the non-wireless versions. The recall covers systems shipped prior to March 2008. The product is designed to provide infusion therapy to patients during magnetic resonance (MR) procedures.

The recall is being issued because of a potential safety risk associated with potentially damaged locking pins within the bracket of the affected systems. The source text does not specify the exact nature of the harm or report any specific injuries or illnesses.

The affected units were distributed worldwide, including in the United States, Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico, and the UAE. Consumers and medical staff should identify their systems by checking the catalog number 3008895 and the specific material and serial numbers listed in the recall documentation.

The recalled product

Product
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after
Manufacturer
Bayer Corp
Affected units
1,347

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 (2)

  • catalog number 3008895 : material numbers 3008236
  • 3009966

Distribution

Distributed nationwide across the United States.