Z-1956-2020 Class II Terminated
FDA device recall Z-1956-2020 was initiated by Merit Medical Systems, Inc. on September 12, 2019 and is designated Class II. 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 o… The recall status is terminated (terminated May 27, 2022). Affected quantity: 15 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- September 12, 2019
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
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.
Distribution Pattern
US Nationwide distribution in the state of MI.
Code Information
Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357