Z-0632-06

Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway...

Name: Z-0632-06 Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway...
Creator: Baxter Healthcare Corp.
Published: 2005-12-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-12-15 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60'', 0.5mL Vol, with male Luer Lock adapter... on 2005-12-15. The reason FDA records is "The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0632-06
Status: Terminated
Initiated: 2005-12-15
Posted: 2006-03-24
Terminated: 2008-08-18
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60'', 0.5mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
FDA root cause: Other
Action: Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
Quantity in commerce: 54,500 sets
Distribution: Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
Product codes and lots: product code 2N3348, lots UR254581, UR255059, UR258806, UR258921

Product code FPA

K811463Class IIAuto-Syringe Micro Volume Extension SetBaxter Healthcare Corp / cleared 1981-06-12

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)