Z-0943-05

Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL...

Name: Z-0943-05 Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL...
Creator: Baxter Healthcare Corp.
Published: 2005-04-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-04-21 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid... on 2005-04-21. The reason FDA records is "There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0943-05
Status: Terminated
Initiated: 2005-04-21
Posted: 2005-06-30
Terminated: 2006-07-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica
Product code: FMG Stopcock, I.V. Set
Reason for recall: There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
FDA root cause: Other
Action: Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit.
Quantity in commerce: 107,832 sets
Distribution: Nationwide and internationally to American Samoa and Venezuela.
Product codes and lots: product code 3C0062s, lot numbers R04D28173, R04D28181, R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020, R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092, R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055, R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060, R05B28192

Product code FMG

K022895Class IIElcam Stopcocks and ManifoldsMedical Device Consultants, Inc. / cleared 2002-10-18

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)