FDA recall Z-0454-2021

Merit Medical Systems, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.

Key facts

Status: Terminated
Initiation date: 2020-09-16
Report date: 2020-11-25
Termination date: 2021-06-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2021