Z-0545-05

Heparin Lock Flush Solution, manufactured by IV Flush LLC

Name: Z-0545-05 Heparin Lock Flush Solution, manufactured by IV Flush LLC
Creator: IV Flush LLC
Published: 2005-01-26
License: https://open.fda.gov/license/

IV Flush LLC / initiated 2005-01-26 / Terminated

FDA source

IV Flush LLC began a recall of Heparin Lock Flush Solution, manufactured by IV Flush LLC on 2005-01-26. The reason FDA records is "Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0545-05
Status: Terminated
Initiated: 2005-01-26
Posted: 2005-03-01
Terminated: 2008-09-17
Recalling firm: IV Flush LLC
Product: Heparin Lock Flush Solution, manufactured by IV Flush LLC
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.
FDA root cause: Other
Action: The firm initiated the recall by fax to distributors on 01/26/2005. On 2/16/2005 the firm faxed a second recall letter with return reciept response card to all consignees.
Distribution: Product was distributed nationwide.
Product codes and lots: All lots remaining on the market.

Product code FOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)