Cultura Flex Swabs (2020-09-17)
- Starting date:
- September 17, 2020
- Posting date:
- October 15, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74133
Last updated:
2020-10-15
Affected Products
A. Cultura Flex Swab
B. Cultura Collection and Transport System
Reason
Merit Medical Systems, Inc. is voluntarily conducting a recall to ensure all users of the Cultura Flex Swabs are employing the proper technique for obtaining samples using nasopharyngeal swabs. The complaint rate for swab breakage during this procedure is extremely low (less than 4 complaints per million units sold).
Affected products
A. Cultura Flex Swab
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
C100F
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Alabama
UNITED STATES
B. Cultura Collection and Transport System
Lot or serial number
H1857517, H1856618, H1856611
Model or catalog number
CFTS100
VCTS100
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Alabama
UNITED STATES