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
FDA Recall Z-0455-2021 · Posted None
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeJSM
Date Initiated2020-09-16
Date Terminated2021-06-01
Product Quantity159,396 units
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.
Firm 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 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.