Z-0889-2010

Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095...

Name: Z-0889-2010 Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095...
Creator: Merit Medical Systems, Inc.
Published: 2010-01-06
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-01-06 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various... on 2010-01-06. The reason FDA records is "Infusion catheters may become brittle and break during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0889-2010
Status: Terminated
Initiated: 2010-01-06
Posted: 2010-03-02
Terminated: 2010-09-13
Recalling firm: Merit Medical Systems, Inc.
Product: Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
Product code: KRA Catheter, Continuous Flush
Reason for recall: Infusion catheters may become brittle and break during use.
FDA root cause: Storage
Action: All affected sales reps were notified by phone and a Mistique Infusion Catheter - Product Recall letter on 01/06/2010 and instructed to contact their accounts, inform them of the recall situation, and complete the Recall Notification form with a site representative. Accounts were to immediately cease use of any affected units and to arrange for return to Merit. Recall actions are to be completed by Jan 22, 2010. Questions should be directed to Greg Turner at 801-316-4998 or Liz Pratt at 801-208-4828.
Quantity in commerce: 40 units
Distribution: Worldwide Distribution -- USA, including states of AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK.
Product codes and lots: Lot Numbers: F682090, F707520, F651485, and F531675.

Product code KRA

K974067Class IIFountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. / cleared 1998-02-27

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)