Z-0074-06

CRITIFLO(tm) flush kit

Name: Z-0074-06 CRITIFLO(tm) flush kit
Creator: Becton Dickinson Medical Systems
Published: 2005-07-01
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2005-07-01 / Terminated

FDA source

Becton Dickinson Medical Systems began a recall of CRITIFLO(tm) flush kit on 2005-07-01. The reason FDA records is "Device could permit an over-infusion of IV solutions during pressure monitoring procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0074-06
Status: Terminated
Initiated: 2005-07-01
Posted: 2005-10-21
Terminated: 2011-08-09
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: CRITIFLO(tm) flush kit.
Product code: KRA Catheter, Continuous Flush
Reason for recall: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
FDA root cause: Other
Action: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Quantity in commerce: 320 units
Distribution: Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..
Product codes and lots: Part Number 687198, Lot Numbers 301850, 302267, 303012, 305055.

Product code KRA

K791844Class IICritiflo & Critiflo DomeGould, Inc. / cleared 1979-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)