Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Recall Z-1254-2025 · Posted 2025-03-06
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Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-02-05
Product Quantity323 units
Reason for Recall
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Firm Action
Baxter issued an "URGENT MEDICAL DEVICE RECAL" notice to its consignees on 02/05/2025 via US Mail. The notice explained the issue, hazard involved, and requested the following actions be taken:
"1. Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump.
2. Contact Baxter to arrange for the return of the affected pumps for inspection and reservicing as applicable.
3. If you received this communication directly from Baxter, acknowledge receipt on the enclosed reply form even if you have no remaining inventory. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification.
4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions.
5. Please forward a copy of this communication to all departments within your institution who use the affected product.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on the customer portal.
For general questions regarding this communication, or quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."
Root Cause
Under Investigation by firm
Distribution Pattern
US: Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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