Class II — Bayer Corp
| Recalling firm | Bayer AG |
|---|---|
| Registered facility | Bayer Medical Care B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. |
| 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 the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff. |
| Quantity | 1347 |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE. |
| Initiated | 2014-04-03 |
| Classified | 2014-05-30 |
| Terminated | 2015-04-16 |
| Recall number | Z-1673-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bayer Corp (Z-1673-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68293/
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