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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recalls |
|---|---|
| Recall Numbers | Z-1810-2024 |
| Risk Class | Class 2 |
| Recall Qty | 9 |
| Classification Date | 2024-05-13 |
| Recall Link | Recall Link |
| Notes/Alerts | N/A |
| Recall Reason | Potential for cracks on the mount of the front panel of the device. |
DEVICE
| Manufacturer | Baxter Healthcare Corp |
|---|---|
| Model Names | Spectrum IQ Infusion pump |
| Model Numbers | 3570009 |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Pump, Infusion |
| Serial Number(s) | 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419 |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Baxter Healthcare. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
