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
ReasonReports of incorrect priming volume due to manufacturing with incorrect tubing.
ProductAlaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.
Quantity25,400 units
DistributionUS Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
Initiated2017-11-06
Classified2018-06-07
Terminated2020-12-07
Recall numberZ-2111-2018
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-2111-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80093/

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