Z-0234-04

Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For...

Name: Z-0234-04 Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For...
Creator: Kendall Healthcare Products Co
Published: 2003-12-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-12-02 / Terminated / root cause: labeling and UDI

FDA source

Kendall Healthcare Products Co began a recall of Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195 on 2003-12-02. The reason FDA records is "Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm". 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-0234-04
Status: Terminated
Initiated: 2003-12-02
Posted: 2003-12-17
Terminated: 2012-05-15
Recalling firm: Medtronic, Inc.
Product: Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195
Product code: MPB Catheter, Hemodialysis, Non-Implanted
Reason for recall: Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.
Quantity in commerce: 10
Distribution: IL, MA, OH, TN, TX, VA
Product codes and lots: Lot Number: 140774

Product code MPB

K030209Class IIMahurkar Oplus Catheter, Model 13.5 FrThe Kendall Company / cleared 2003-05-13

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)