FDA Device recall Z-1368-2026
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump,…
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump,… by Baxter Healthcare, citing pumps were released without full testing being performed, including occlusion alarm testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1368-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-13 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Baxter Healthcare |
| Distribution | OH |
Product
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Reason
Pumps were released without full testing being performed, including occlusion alarm testing.
Identifiers
| code_info | Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1368-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.