Z-0456-2021 Class II Terminated
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
- 371,528 units
Product Description
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
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)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911