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
ReasonCareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
ProductVersaSafe Extension Set, Model No. 21000M-007
Quantity3500 units
DistributionNationwide Distribution.
Initiated2013-11-08
Classified2013-12-03
Terminated2014-04-17
Recall numberZ-0435-2014
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-0435-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66758/

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