Z-0161-2010

Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter...

Name: Z-0161-2010 Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter...
Creator: Medical Components, Inc dba MedComp
Published: 2009-09-02
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2009-09-02 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits on 2009-09-02. The reason FDA records is "mislabeled as right are actually left". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0161-2010
Status: Terminated
Initiated: 2009-09-02
Posted: 2009-11-10
Terminated: 2010-04-16
Recalling firm: Medical Components, Inc.
Product: Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: mislabeled as right are actually left
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.
Quantity in commerce: 100 trays
Distribution: Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.
Product codes and lots: Lot Number: MAVV890, exp 2014/07.

Product code MSD

K971925Class IIMedcomp Bio-Flex Cs Catheter (Cs100)Medical Components, Inc. / cleared 1998-02-23

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)