Medrad Continuum MR Infusion system- non-wireless system The MEDRAD… — Class II medical device recall Z-1673-2014
Terminated recall by Bayer Corp, reported 2014-06-11, distributed nationwide. There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wi
| Recall number | Z-1673-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Corp, Warrendale, PA, United States |
| Recall initiated | 2014-04-03 |
| Classified | 2014-05-30 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2015-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, DE, MX, PL, SG, ZA |
| Quantity | 1,347 |
| Serial numbers | 1000, 100000, 100001, 100002, 100003, 100004, 100005, 100006, 100008, 100009, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100022, 100023, 100024, 100025, 100026, 100027 and 475 more |
| Model numbers | 3008895 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1673-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.