—#183901

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

FDA product code: KXG — Applicator, Absorbent Tipped, Sterile
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.

Timeline

Recall initiated: 2020-09-16
Terminated: 2021-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.