Z-2693-2011

THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit

Name: Z-2693-2011 THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit
Creator: Medical Components, Inc dba MedComp
Published: 2011-05-19
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2011-05-19 / Terminated / root cause: packaging

FDA source

Medical Components, Inc dba MedComp began a recall of THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit on 2011-05-19. The reason FDA records is "Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2693-2011
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-06-28
Terminated: 2016-10-24
Recalling firm: Medical Components, Inc.
Product: THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.
Quantity in commerce: 90
Distribution: Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands
Product codes and lots: Lot # MAZX990; Catalog # THD155428, Exp Date 2013/03

Product code MSD

K030502Class II14.5F X 55Cm Hemo-Flow Double Lumen Catheter, Models Hfs-55, Hft-55Medcomp / cleared 2003-05-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)