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Recall Observatory FDA recall evidence

Device product

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

Z-0629-2024

November 06, 2023

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 93461
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0629-2024

Official wording

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

Code information: REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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