FDA Medical Device Recalls (openFDA)
Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics: Infusion Dynamics Power Infuser pump. Model number M100B-3A
- Recall number
- Z-0062-05
- Recalling firm
- Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics
- Product
- Infusion Dynamics Power Infuser pump. Model number M100B-3A
- Status
- Terminated
- Initiated
- 2004-09-21
- Posted
- 2004-11-02
- Terminated
- 2005-02-07
- Reason
- Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.
- Root cause
- Other
- Action
- The recalling firm issued a recall letter dated 9/20/04 to their customers informing them of the problem and the need to return the units.
- Quantity
- 255 units
- Distribution
- The products were shipped to dealers in TX, MO, and VT; medical facilities in CA, NV, and NY. The product was also shipped to government accounts in PA and Germany.
- Lot, serial or model codes
- Serial numbers 13-05863 through 13-05929 and 13-6005 through 13-06036
- 510(k) numbers
- ["K030739","K992044"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3002608078
- Firm city
- Plymouth Meeting
- 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