Recall Z-0107-2019
Baxter Healthcare Corporation · initiated September 18, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Codes / lots: UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
Reason for recall
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
FDA-determined cause: Software design
Action taken
The firm initiated their field correction by email on 09/14/2018. The notice alerted the consignee of the problem and stated that Baxter would be issuing a software update to correct the issue.
Details
- Recall number
- Z-0107-2019
- Initiated
- September 18, 2018
- Terminated
- August 19, 2020
- Product code
- PHC – Infusion Safety Management Software
- Quantity
- 354 units
- Distribution
- NJ
- Recalling firm
- Baxter Healthcare Corporation, Medina, NY