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)20884450491106
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling MeritMedical Cultura Flex Swab sterile flocked collection devices (100mm swabs, reference C100F) distributed worldwide to multiple countries including the United States, Australia, Canada, and others. The recall affects approximately 3.4 million units from all lots distributed before August 28, 2020. The flocked tip of these swabs may break off inside the nasopharyngeal cavity during sample collection, which could cause soft tissue injury or delay medical treatment.
The recall notice does not specify a remedy for consumers who may have received or used these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 3,385,442 units Lot/code info: All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.