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U.S. Department of Health and Human Services

Class 2 Device Recall Cultura Collection and Transport System

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  Class 2 Device Recall Cultura Collection and Transport System see related information
Date Initiated by Firm September 16, 2020
Create Date November 16, 2020
Recall Status1 Terminated 3 on June 01, 2021
Recall Number Z-0455-2021
Recall Event ID 86522
Product Classification Culture media, non-propagating transport - Product Code JSM
Product 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
Code Information All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Cory Marsh
801-316-3690
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 159,396 units
Distribution Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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