# FDA recall Z-0455-2021

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2020-09-16.

## 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

## 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

- **Recall number:** Z-0455-2021
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0455-2021

## Citation

> AI Analytics. FDA recall Z-0455-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0455-2021. Source: US FDA. Licensed CC0.

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