Z-0454-2021Class II

MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit...

Name: Z-0454-2021 MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit...
Creator: Merit Medical Systems, Inc.
Published: 2020-09-16
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2020-09-16 / Terminated / root cause: design

FDA source

Merit Medical Systems, Inc. began a recall of MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit -... on 2020-09-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0454-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-16
Posted: 2020-11-16
Terminated: 2021-06-01
Recalling firm: Merit Medical Systems, Inc.
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
Product code: KXG Applicator, Absorbent Tipped, Sterile
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.
Root cause tag: design
FDA 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 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: 3,385,442 units
Distribution: Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
Product codes and lots: All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0454-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0454-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-16
Z-0455-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-16
Z-0456-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-16

Product code KXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)