Merit Medical Systems, Inc.: Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492

Is my product affected?

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

• UPC 00884450492123
• UPC 10884450492120
• UPC 20884450492127

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

What happened

Merit Medical Systems, Inc. is recalling the Merit Medical Cultura Collection and Transport System (Ref CFTS100), a single-use in vitro diagnostic device for nasopharyngeal sample collection. The flocked tip of the 100mm swab in this product may break off inside the nasopharyngeal cavity during sample collection, which could cause soft tissue injury or delay in treatment. The recall affects 159,396 units distributed worldwide, including throughout the United States, Australia, Canada, and multiple other countries. All lots distributed prior to August 28, 2020 are included in the recall.

The affected products include single units with barcode 00884450492123, 50-unit packages with barcode 10884450492120, and 200-unit packages with barcode 20884450492127. The source document does not specify what remedy or action affected consumers should take 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: 159,396 units Lot/code info: All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilat2020-09-16
• MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)208844504911062020-09-16
• 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)208844504999112020-09-16
• Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).2020-09-15
• Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).2020-09-15

All FDA (Device enforcement) recalls