Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed…
Medical device recall Z-1673-2014. Published in FDA’s Enforcement Report on Jun 11, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 11, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1347 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1347, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
catalog number 3008895 : material numbers 3008236, 3009966, 3009917 with serial numbers: 1048 200619 200585 200656 300010 100066 14498 100087 200305 200663 200248 200606 300047 1040 100182 100187 200442 200037 200716 200111 300051 1041…
Every code shown here, 1,994 characters
catalog number 3008895 : material numbers 3008236, 3009966, 3009917 with serial numbers: 1048 200619 200585 200656 300010 100066 14498 100087 200305 200663 200248 200606 300047 1040 100182 100187 200442 200037 200716 200111 300051 1041 100428 100128 200479 200586 200648 200009 300045 100107 100037 100213 200665 200034 200722 200134 300027 100272 100457 100215 200601 200109 200298 200135 100220 100273 100482 100141 200615 200121 200558 200593 300036 100401 11210 100488 200117 200313 200618 200465 300033 100409 10328 100129 200540 200515 200187 1045 300034 100404 15187 100083 200401 200119 20398 200045 300042 100299 10407 100006 200115 1068 200051 14857 300026 100300 100233 100188 200432 200267 1073 200557 300049 100399 100266 100226 200497 200689 200022 200322 30020 100400 14076 100271 200200 200771 200089 200346 300013 100184 100265 100069 200012 200075 200090 200655 300012 100185 1033 1047 200706 200076 200091 200509 300000 100405 100316 100098 200707 1047 200344 1006 200004 100173 100356 100051 200493 200031 200337 200175 300001 100174 10810 100148 200419 200512 200644 200103 300002 100259 100144 100297 200597 200430 200579 200436 300003 100283 100105 100449 100122 200348 200580 200104 300028 100375 14163 100452 200393 200276 200463 200105 300055 1000 11159 100454 200392 200205 200079 200204 300032 100517 100027 100458 200674 200469 200328 200443 300031 100518 100279 100072 200193 200268 200040 200444 300044 100521 100139 100084 200324 200000 200030 200225 300015 100212 100175 11132 200289 200627 200395 200421 1021 100284 14246 100304 200415 200583 200388 200396 300037 100036 100443 100257 200416 200087 200682 200047 300025 100545 100492 100447 200448 200136 200164 1020 300016 100433 100497 100529 200482 200137 200778 1012 300017 100434 100170 100487 200483 200270 200568 200124 300019 1019 100019 100537 200574 200581 200185 1008 300006 100296 14464 100515 200587 200641 200043 1064 300029 100135 10387 10213 200598 200213 200160 200049 300062 1038 14846 11179…
FDA’s list runs to 9,226 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 3, 2014.
- FDA classified it on May 30, 2014.
- FDA’s Enforcement Report published it on Jun 11, 2014.
- FDA terminated it on Apr 16, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bayer Corp, of Warrendale, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,226 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.