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FDA (Device enforcement)Recalled 2023-11-06class ii

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

Hazard

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

Details from the source

Reason for recall: The sterility of microcatheter and infusion system devices cannot be guaranteed. 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. Quantity: 59 units Lot/code info: 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

UPC codes

00884450315453, 00884450358566, 00884450358726, 00884450358733, 00884450315408

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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