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Merit Pursue recallZ-0628-2024 · Merit Medical Systems, Inc. · initiated Nov 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The sterility of microcatheter and infusion system devices cannot be guaranteed.

FDA root cause category: Package design/selection

What the company is doing

On November 6, 2023, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via Email or UPS. Merit Medical asked consignees to take the following actions: 1. Immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within seven (7) days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.

Recall details

Recall number
Z-0628-2024
Status
Open, Classified
Initiated by the company
Nov 6, 2023
Posted by the FDA
Jan 2, 2024
Recalling firm
Merit Medical Systems, Inc.
Quantity
59 units
Product code
DQY
FDA submissions
K173548
Distribution
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.

Product description

Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY

Code information (models, lots, serial numbers)

Ref:28HC17130SN - Lot# H2769793 - UDI:00884450315453 REF: 28HC17150ST/A - Lot# H2767389 - UDI:00884450358566 REF: 29HC2015045/A - Lot # H2750582 - UDI: 00884450358726 Ref: 29HC20150SN/A - Lot# H2750587 - UDI: 00884450358733 29HC20150ST H2765980 00884450315408

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93461).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page