Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0455-2021 — 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

U.S. FDA — Device Enforcement · United States · 2020-09-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0455-2021
Date of alert
2020-09-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merit Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884450492123
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.