Recalls / —
—#207238
Product
Spectrum IQ Infusion pump, Product Code 357009
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K230041
- Affected lot / code info
- UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419
Why it was recalled
There is a potential for cracks on the mount of the front panel of the device.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- US Nationwide distribution in the states of Ohio, Wisconsin.
Timeline
- Recall initiated
- 2024-04-09
- Posted by FDA
- 2024-05-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #207238. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.