Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
FDA Recall Z-0629-2024 · Posted 2024-01-02
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeQEY
Date Initiated2023-11-06
Product Quantity3 units
Reason for Recall
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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