Z-0853-05

Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow...

Name: Z-0853-05 Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow...
Creator: Baxter Healthcare Corp.
Published: 2005-03-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-03-03 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock... on 2005-03-03. The reason FDA records is "Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0853-05
Status: Terminated
Initiated: 2005-03-03
Posted: 2005-06-01
Terminated: 2006-05-11
Recalling firm: Baxter Healthcare Corporation
Product: Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; 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: Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
FDA root cause: Other
Action: Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Quantity in commerce: not known
Distribution: Nationwide
Product codes and lots: product code 2N9050, all lots

Product code FPA

K964918Class IINima Needleless Injectionsite Master Adapter with Posiflow Positive Displacement Feature, and i.v. SetsCritical Device Corp. / cleared 1997-04-14

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)