Merit Medical Cultura Collection and Transport System Swab Tip Breakage Recall
Merit Medical is recalling Cultura Collection and Transport Systems because the swab tip may break off during sample collection, potentially causing soft tissue injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury (soft tissue injury) is a potential consequence, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Cultura Collection and Transport System, 3 mL Viral Transport Medium (Ref: VCTS100). The recall involves 371,528 units distributed worldwide, including the United States, Australia, Canada, and other countries. The affected lots are those distributed prior to August 28, 2020.
The recall was initiated because the flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This defect could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Healthcare providers and consumers should stop using the affected devices and contact Merit Medical Systems for further instructions or a replacement.
The recalled product
- Product
- Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 371,528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All Lots distributed prior to August 28
- 2020. 1 Unit - (01)00884450499917
- 50 Units - (01)10884450499914
- 200 units - (01)20884450499911
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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