Z-0694-05

Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053...

Name: Z-0694-05 Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053...
Creator: Baxter Healthcare Corp.
Published: 2005-01-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-01-20 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid... on 2005-01-20. The reason FDA records is "Product older than three years may not operate as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0694-05
Status: Terminated
Initiated: 2005-01-20
Posted: 2005-04-08
Terminated: 2006-04-14
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson
Product code: FPA Set, Administration, Intravascular
Reason for recall: Product older than three years may not operate as intended.
FDA root cause: Other
Action: Urgent Product Recall letters dated 1/20/05 were sent to the direct accounts via first class mail, to the attention of the Director of Purchasing. The accounts were informed that the Posiflow Luer Activated valves may not operate as intended if the product is older than three years. The accounts were instructed to examine their inventories of the affected product codes listed to determine if they have any product on hand without expiration dating, and remove any found from inventory. The expiration date, if present, may be found on both the individual product package and on the end panel label of the product shipping carton. The accounts were instructed to call Baxter at 1-888-229-0001 to arrange for the return of any product found without an expiration date. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 1,585,542 units
Distribution: Nationwide, including American Samoa, and internationally to Venezuela.
Product codes and lots: product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots without expiration dating

Product code FPA

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)