Baxter Healthcare Corporation recalls Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 So…
Reason for recall
Pumps were released without full testing being performed, including occlusion alarm testing.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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/AGTIN 000854126109006 affected lots0008541261090038156633823468382474338252343825599
What the firm is doing
Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.
DistributionShow detailsHide
States: Ohio Countries: United States
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1368-2026
- FDA 510(k) clearance · K251636The device's official FDA premarket clearance record
- FDA device classification · FRNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5725The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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