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Recall Observatory FDA recall evidence

Device product

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

Z-0628-2024

November 06, 2023

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 93461
Status
Ongoing
Classification
Class II
Quantity
59 units
Official record key
device-enforcement:Z-0628-2024

Official wording

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

Code information: 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

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.