Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling 15 Custom Sheath Introducer Kits (Catalog Number K21-00031, Lot Number H1583914) distributed nationwide in Michigan. These kits are designed to provide access for introducing medical devices into veins. Due to a manufacturing error, the product packages were labeled with incorrect sheath sizes and contained incorrect sheath assemblies that do not match the labeling.
Using the incorrect kit components could cause vasoconstriction, moderate hemorrhage, and/or embolism. The recall affects only kits with the specified lot number. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
Reason for recall: labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism. Distribution: US Nationwide distribution in the state of MI. Quantity: 15 kits Lot/code info: Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.