Merit Medical Systems, Inc.: 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)008844504999

Is my product affected?

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

• UPC 00884450499917
• UPC 10884450499914
• UPC 20884450499911

Check against the official notice below — it lists the full affected range.

What happened

Merit Medical Systems is recalling the Cultura Collection and Transport System, a viral transport medium kit used for sample collection, because the flocked tip of the 100mm swab may break off inside the nasopharyngeal cavity during sample collection. If the tip breaks off, it could cause soft tissue injury to the nasopharyngeal cavity or delay treatment. The recall affects approximately 371,528 units distributed worldwide, including in the United States, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, and Trinidad and Tobago. All lots distributed before August 28, 2020 are affected.

The source document does not specify what consumers or healthcare providers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 371,528 units Lot/code info: All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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