Merit Medical Systems, Inc.: Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, 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: 3 units Lot/code info: REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504

UPC codes

00884450000885, 00884450006504

Source

Official record: FDA (Device enforcement) ↗

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