Z-0453-03

Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116...

Name: Z-0453-03 Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116...
Creator: Baxter Healthcare Corp.
Published: 2002-12-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2002-12-18 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber... on 2002-12-18. The reason FDA records is "Leakage may occur at the inlet port". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0453-03
Status: Terminated
Initiated: 2002-12-18
Posted: 2003-01-16
Terminated: 2003-09-30
Recalling firm: Baxter Healthcare Corporation
Product: Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015
Product code: KSB Set, Transfer (Blood/Plasma)
Reason for recall: Leakage may occur at the inlet port
FDA root cause: Other
Action: The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.
Quantity in commerce: 6,724
Distribution: Nationwide
Product codes and lots: Lots GR182865, GR184309, GR186569

Product code KSB

K881321Class IIBlood/solution Set W/pressure PumpBaxter Healthcare Corp / cleared 1988-06-16

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)