Z-0629-2024Class II

Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY

Name: Z-0629-2024 Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Creator: Merit Medical Systems, Inc.
Published: 2023-11-06
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2023-11-06 / Open, Classified / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY on 2023-11-06. FDA classified it as Class II and gives the reason as "The sterility of microcatheter and infusion system devices cannot be guaranteed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0629-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2024-01-02
Recalling firm: Merit Medical Systems, Inc.
Product: Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Product code: QEY Mechanical Thrombolysis Catheter
Reason for recall: The sterility of microcatheter and infusion system devices cannot be guaranteed.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 3 units
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 codes and lots: REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0629-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0627-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-02
Z-0628-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-02
Z-0629-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-02

Product code QEY

K992231Class IIFOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. / cleared 1999-07-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)