Z-0455-2021 Class II Terminated
FDA device recall Z-0455-2021 was initiated by Merit Medical Systems, Inc. on September 16, 2020 and is designated Class II. 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. The recall status is terminated (terminated June 1, 2021). Affected quantity: 159,396 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- September 16, 2020
- Termination Date
- June 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159,396 units
Product Description
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 Pattern
Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
Code Information
All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127