Skip to content
Recall Observatory FDA recall evidence

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

Z-0454-2021

September 16, 2020

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 86522
Status
Terminated
Classification
Class II
Quantity
3,385,442 units
Official record key
device-enforcement:Z-0454-2021

Official wording

Reason: 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.

Code information: All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.