Recall Z-1150-2021— Baxter Healthcare Corporation
Class II · Completed
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-01-06. It names 3 FDA 510(k) clearances: K173084, K133801, K042121. Product: Infusion Pump. Reason: Battery performance issues related to prolonged storage..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-01-06
- Firm location
- Medina, NY, United States
510(k) clearances named in this recall
3 on FDA's record- K173084 — Spectrum IQ Infusion System, Dose IQ Safety Software
- K133801 — BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
- K042121 — SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Infusion Pump
Reason for recall
Battery performance issues related to prolonged storage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.