Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 8/12/2020
Class I
PRODUCT
CADD Medfusion Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Recall Number: Z-2734-2020
REASON
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD Inc. on 6/26/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
35616 units
DISTRIBUTION
International