Z-1103-05

Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male...

Name: Z-1103-05 Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male...
Creator: Baxter Healthcare Corp.
Published: 2005-07-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-07-06 / Terminated / root cause: sterility

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation... on 2005-07-06. The reason FDA records is "Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1103-05
Status: Terminated
Initiated: 2005-07-06
Posted: 2005-08-06
Terminated: 2007-01-31
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
Root cause tag: sterility
FDA root cause: Other
Action: Baxter sent Urgent Product Recall letters dated 7/6/05 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 complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. 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.
Quantity in commerce: 840 sets
Distribution: Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.
Product codes and lots: product code 1C8689, lot GD814186

Product code FPA

K791496Class IILow Plasticizer Administration SetsTravenol Laboratories, S.A. / cleared 1980-04-08

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)