PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 10, 2024 Initiated: November 6, 2023 #Z-0628-2024

Product Description

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

Reason for Recall

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

Details

Units Affected
59 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.
Location
South Jordan, UT

Frequently Asked Questions

What product was recalled?
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY. Recalled by Merit Medical Systems, Inc.. Units affected: 59 units.
Why was this product recalled?
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 10, 2024. Severity: Moderate. Recall number: Z-0628-2024.