medical Class II Updated 2020-11-25

Merit Medical Systems, Inc. recalls Merit Medical Cultura Collection and Transport System, Ref C

Recalled Product

Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127

Hazard / Issue

The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
View official government recall

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