Recall Z-0454-2021 ยท KXG Applicator, Absorbent Tipped, Sterile
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
| Date | Sep 16, 2020 |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 |
| Quantity | 3,385,442 units |
| Distribution | Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.