Device 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
Z-1368-2026
Product summary
- Event
- Event 98306
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-1368-2026
Official wording
Reason: Pumps were released without full testing being performed, including occlusion alarm testing.
Code information: Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Distribution pattern: States: Ohio Countries: United States
Derived failure modes
-
Unknown
Pumps were released without full testing being performed, including occlusion alarm testing.