Recall Z-0455-2021— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2020-09-16, terminated 2021-06-01. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-16
- Terminated
- 2021-06-01
- Firm location
- South Jordan, UT, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.