FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Mistique Infusion Catheter, MIC5-135-20-035, 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.
- Recall number
- Z-0886-2010
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Mistique Infusion Catheter, MIC5-135-20-035, 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.
- Status
- Terminated
- Initiated
- 2010-01-06
- Posted
- 2010-03-02
- Terminated
- 2010-09-13
- Reason
- Infusion catheters may become brittle and break during use.
- 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
- 11 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.
- Lot, serial or model codes
- Lot Numbers: F691136, F523171, and F725674.
- 510(k) numbers
- ["K974067"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28