RegWardenFDA facility compliance records
Recall

Class II — CareFusion 303, Inc.

Recalling firmCareFusion 303, INC.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonDisconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
ProductSmartSite Extension Set, Model No. 20029E, intravascular administration set.
Quantity7,700 units
DistributionUSA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
Initiated2014-03-19
Classified2014-04-15
Terminated2015-06-06
Recall numberZ-1459-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — CareFusion 303, Inc. (Z-1459-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67774/

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