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.
Reported: May 20, 2020 Initiated: September 12, 2019 #Z-1956-2020
Product Description
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.
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.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 15 kits
- Distribution
- US Nationwide distribution in the state of MI.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merit Medical Systems, Inc.. Units affected: 15 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1956-2020.
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