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Recall Observatory FDA recall evidence

Device product

Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911

Z-0456-2021

September 16, 2020

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 86522
Status
Terminated
Classification
Class II
Quantity
371,528 units
Official record key
device-enforcement:Z-0456-2021

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)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911

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.