Z-0925-03

StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K

Name: Z-0925-03 StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K
Creator: Venetec Intl Inc
Published: 2003-05-12
License: https://open.fda.gov/license/

Venetec Intl., Inc. / initiated 2003-05-12 / Terminated

FDA source

Venetec Intl Inc began a recall of StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K on 2003-05-12. The reason FDA records is "Set tubing disconnected from the male luer lock during use on patients. Misassembled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0925-03
Status: Terminated
Initiated: 2003-05-12
Posted: 2003-06-12
Terminated: 2003-10-14
Recalling firm: Venetec Intl., Inc.
Product: StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Set tubing disconnected from the male luer lock during use on patients. Misassembled.
FDA root cause: Other
Action: A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.
Quantity in commerce: 3150 units
Distribution: One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
Product codes and lots: Lot D207201

Product code FPA

K980992Class IIIV Administration Sets with Needleless Access DevicesVenetec Intl., Inc. / cleared 1998-05-28

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)