Recall Z-1362-2020— CareFusion 303, Inc.
Class I · Ongoing
Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-02-04. It names 2 FDA 510(k) clearances: K051641, K012383. Product: CareFusion Alaris PCA Module, Model 8120. Reason: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders.
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2020-02-04
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001
- K012383 — GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
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
CareFusion Alaris PCA Module, Model 8120
Reason for recall
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Data sourced from openFDA. This site is unofficial and independent of the FDA.