Recall Z-1956-2020— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2019-09-12, terminated 2022-05-27. It names one FDA 510(k) clearance: K173750. Product: 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: 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..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-12
- Terminated
- 2022-05-27
- Firm location
- South Jordan, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.