Merit Medical Systems, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Products Sold
All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Merit Medical Systems, Inc. is recalling MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the foll due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm sent an recall notification on September 16, 2020 to all affected consignees. In addition to informing consignees about the correction, the firm requested consignees take the following action: 1. Please refer to the attached instructions and/or linked instructional video when collecting samples with nasopharyngeal swabs. 2. Ensure that applicable personnel within your organization are made aware of this notice. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4. If you have any questions or concerns regarding this communication or the products addressed, please contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026