FDA Enforcement
Class II
Ongoing
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Recall: Z-1775-2024
·
Reported May 15, 2024
Enforcement
- Recall Number
- Z-1775-2024
- Event ID
- 94446
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 15, 2024
- Initiation Date
- March 20, 2024
- Classification Date
- May 3, 2024
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Reason
One device was improperly performed testing prior to release from a Service Center.
Code Info
UDI/DI 00085412610900, Serial Number 3540772
Distribution
US Nationwide distribution in the state of Massachusetts.
Quantity
1 pump