Z-0841-05

Continuum MR Compatible Infusion Pump. Pump Model #3009135

Name: Z-0841-05 Continuum MR Compatible Infusion Pump. Pump Model #3009135
Creator: Medrad Inc
Published: 2005-03-22
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2005-03-22 / Terminated

FDA source

Medrad Inc began a recall of Continuum MR Compatible Infusion Pump. Pump Model #3009135 on 2005-03-22. The reason FDA records is "Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0841-05
Status: Terminated
Initiated: 2005-03-22
Posted: 2005-05-13
Terminated: 2005-08-17
Recalling firm: Medrad, Inc.
Product: Continuum MR Compatible Infusion Pump. Pump Model #3009135
Product code: FRN Pump, Infusion
Reason for recall: Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.
FDA root cause: Other
Action: The recalling firm issued a Field Correction letter dated 3/9/05 to all their customers. The letter instructed the consignee on how to apply the new warning labels, to discard the old Operation Manual and replace it with the new one.
Quantity in commerce: 461 units
Distribution: The products were shipped nationwide to hospitals and outpatient MRI office. The product was shipped to government facilities in CA, DC, MD, NJ, SC, WA, and WV. The product was also shipped to Austriala, Canada, Mexico, United Arib, Austria, Germany, Denmark, France, Great Britain, Hong Kong, Iceland, Italy, Netherlands, Norway, Portugal, Sweden, and Singapore.
Product codes and lots: Serial numbers 1000 through 300017

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)