FDA-Device2020-11-25Class II
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Merit Medical Systems, Inc.
Hazard
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.
Sold states
Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
Affected count
3,385,442 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2021Don't want to check this manually?
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