Z-1048-05

Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink...

Name: Z-1048-05 Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink...
Creator: Baxter Healthcare Corp.
Published: 2005-05-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-05-31 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured... on 2005-05-31. The reason FDA records is "Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1048-05
Status: Terminated
Initiated: 2005-05-31
Posted: 2005-07-28
Terminated: 2006-05-23
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product code 2N3709
Product code: FPA Set, Administration, Intravascular
Reason for recall: Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Baxter sent Urgent Product Recall dated 5/31/05 to their customers on the same date, to the attention of the Director of Materials Management. The accounts were informed of the potential mislabeling, and were requested to check their inventory of any product code labeled 2N3703 or 2N3709 with lot number FC04058. If any of the affected lot is found the accounts were instructed to call Baxter Healthcare Center for Service at 1-888-229-0001 to arrrange for product return and replacement. Any questions were referred to the Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 4,850 sets
Distribution: Arkansas, Florida, Texas, North Carolina, Wisconsin and Japan.
Product codes and lots: Lot FC04058

Product code FPA

K961495Class IIHuber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site, Interlink T-Injection SiteBaxter Healthcare Corp / cleared 1996-06-26

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)