ClearanceBrief
Recall Z-0148-2022 ยท FPA Set, Administration, Intravascular

Smiths Medical ASD Inc.

CADD Administration Sets, Model #21-7346-24

DateJul 14, 2020
StatusTerminated
ReasonProduct may have been manufactured with an air filter assembled in an incorrect orientation.
Root causeProcess control
ActionThe firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at fieldactions@smiths-medical.com.
Quantity371 units
DistributionCanada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
Deltec, Inc., May 23, 2003