FDA Medical Device Recalls (openFDA)
Medrad Inc: Continuum MR Compatible Infusion Pump. Pump Model #3009135
- Recall number
- Z-0841-05
- Recalling firm
- Medrad Inc
- Product
- Continuum MR Compatible Infusion Pump. Pump Model #3009135
- Status
- Terminated
- Initiated
- 2005-03-22
- Posted
- 2005-05-13
- Terminated
- 2005-08-17
- Reason
- Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.
- 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
- 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.
- Lot, serial or model codes
- Serial numbers 1000 through 300017
- 510(k) numbers
- ["K021988","K032771"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28