FDA Medical Device Recalls (openFDA)
Harvard Clinical Technology: Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
- Recall number
- Z-0433-05
- Recalling firm
- Harvard Clinical Technology
- Product
- Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
- Status
- Terminated
- Initiated
- 2004-11-03
- Posted
- 2005-01-26
- Terminated
- 2012-05-07
- Reason
- Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- Root cause
- Other
- Action
- Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.
- Quantity
- 204 units
- Distribution
- AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,
- Lot, serial or model codes
- Serial number range 218002222 - 218002382 02R00222 - 02R002382 318002383 - 318002426
- 510(k) numbers
- ["K033054"]
- PMA numbers
- not on file
- Product code
- MEA
- Firm FEI
- 1218257
- Firm city
- Natick
- Firm state
- MA
- 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