Infusion Dynamics Power Infuser pump. Model number M100B-3A
FDA device recall Z-0062-05 · posted 2004-11-02 · Terminated
Recall details
- Recalling firm
- Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 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.
- Date initiated
- 2004-09-21
- Date posted
- 2004-11-02
- Date terminated
- 2005-02-07
- Location
- Plymouth Meeting, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE (K030739) | Infusion Dynamics, Inc. | 2004-01-14 |
| INFUSION DYNAMICS POWER INFUSER MODEL M100B (K992044) | Infusion Dynamics, Inc. | 1999-09-08 |