Reported Nov 25, 2020 · Terminated
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile
- for the following unit count
1 unit - (01)0088445049110225 unit - (01)10884450491109100 unit - (01)20884450491106
- Lot codes and dates
All Lots distributed prior to August 282020. 1 unit - (01)0088445049110225 unit - (01)10884450491109100 unit - (01)20884450491106
- Amount recalled
- 3,385,442 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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